Decal B12-N Syrup 120 mL
1. Disclaimer
This drug-information summary is provided for educational and reference purposes only. It is not a substitute for the current official package leaflet, a physician’s diagnosis, or advice from a qualified pharmacist or other healthcare professional. Product formulations, indications, dosing instructions, regulatory status, and labeling may change between countries and over time; therefore, the package and current official regulatory information for the specific marketed product should always take precedence.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
The information below should not be used to diagnose, treat, or prevent an individual medical condition or to determine a patient-specific dose.
2. Summary
Decal B12-N Syrup 120 mL is an oral liquid preparation manufactured by Amriya Pharmaceutical Industries, Alexandria, Egypt, containing calcium, vitamin D3 (cholecalciferol), and vitamin B12 (cyanocobalamin).
The available regulatory leaflet for DECAL B12 Syrup specifies, per 5 mL:
- Calcium levulinate: 50 mg
- Vitamin D3: 1,000 IU
- Vitamin B12: 10 micrograms
The same regulatory record identifies the dosage form as an oral syrup in a 120 mL bottle and lists Amriya Pharmaceutical Industries as the marketing authorization holder/manufacturer.
Current Egyptian-market listings for Decal B12-N Syrup 120 mL continue to identify the product as manufactured by Amriya. However, several current commercial databases describe the calcium component as calcium gluconate, creating a formulation-label discrepancy that should not be silently resolved without access to the latest Egyptian manufacturer/authority leaflet.
3. Brand Name
Decal B12-N Syrup 120 mL
The product is also listed as DECAL B12 Syrup in the available regulatory leaflet. Current Egyptian-market listings use Decal B12-N Syrup 120 mL.
4. Category
Calcium + Vitamin D3 + Vitamin B12 preparation
Therapeutic/pharmacological classification: calcium and vitamin D-containing preparation, with added vitamin B12.
The Saudi regulatory database assigns the product to ATC A12AX — Calcium, combinations with other drugs.
5. Active Ingredient
According to the available regulatory product information:
- Calcium levulinate
- Cholecalciferol (Vitamin D3)
- Cyanocobalamin (Vitamin B12)
Strength per 5 mL:
- Calcium levulinate 50 mg
- Vitamin D3 1,000 IU
- Vitamin B12 10 mcg
These quantities correspond directly to the regulatory leaflet's stated composition of 1 g calcium levulinate, 20,000 IU cholecalciferol, and 0.2 mg cyanocobalamin per 100 mL.
Important formulation note: Some current Egyptian commercial listings identify the calcium component as calcium gluconate. This conflicts with the available regulatory leaflet and older product documentation, which specify calcium levulinate. This discrepancy should be resolved from the current Egyptian pack/leaflet before treating "calcium gluconate" as the definitive active ingredient.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Oral syrup.
Pack size: 120 mL bottle.
Strength per 5 mL:
- Calcium levulinate 50 mg
- Vitamin D3 1,000 IU
- Vitamin B12 10 mcg
The available regulatory description characterizes the preparation as a clear, bright-red/fruity oral syrup supplied in a 120 mL bottle.
7. Manufacturer & Marketing Authorization Holder
Amriya Pharmaceutical Industries
Address given in the available regulatory leaflet:
Kilo 25, Alexandria–Cairo Desert Road, Alexandria, Egypt.
The available regulatory record identifies Amriya Pharmaceutical Industries as both the marketing authorization holder and manufacturer.
8. Mechanism of Action
Calcium
Calcium is an essential mineral involved in bone and tooth mineralization, neuromuscular function, muscle contraction, and intracellular signaling. Oral calcium is absorbed primarily in the small intestine.
Vitamin D3
Cholecalciferol is converted in the body to active vitamin D metabolites. Vitamin D promotes intestinal calcium and phosphate absorption and contributes to normal bone mineralization and calcium homeostasis.
Vitamin B12
Cyanocobalamin is a form of vitamin B12. Vitamin B12 is required for normal DNA synthesis, red blood cell formation, and neurological function. It also participates in normal cellular metabolism.
The three components therefore address different aspects of mineral and vitamin physiology rather than acting through a single pharmacological mechanism.
9. Spectrum of Activity
Not applicable.
Decal B12-N is not an antimicrobial drug and does not have an antibacterial, antiviral, antifungal, or antiparasitic spectrum of activity.
Its effects are nutritional/physiological and relate primarily to calcium, vitamin D, and vitamin B12 status.
10. Pharmacokinetics
Calcium
Calcium is absorbed mainly from the small intestine through active transport and passive diffusion. The proportion absorbed varies with dietary factors, intestinal condition, vitamin D status, and physiological requirements.
Unabsorbed calcium is eliminated principally in the feces, while absorbed calcium is regulated and eliminated through several routes, including renal excretion.
Vitamin D3
Vitamin D3 is a fat-soluble vitamin and undergoes metabolic conversion to active metabolites. Its pharmacokinetics are more complex than those of a simple water-soluble vitamin, and the available product documentation does not provide a detailed modern pharmacokinetic profile for this specific formulation.
Vitamin B12
Vitamin B12 absorption normally involves binding to intrinsic factor followed by receptor-mediated absorption in the terminal ileum. It is extensively protein-bound and stored in the body, particularly in the liver.
The available product documentation reports hepatic metabolism and urinary elimination and gives a reported half-life of approximately 6 days; however, pharmacokinetic parameters for oral cyanocobalamin can vary according to dose, absorption pathway, and patient status.
11. Indications
The original product information describes use for prevention/treatment of deficiencies involving calcium, vitamin D, and vitamin B12.
The available regulatory leaflet specifically lists use in:
- Vitamin D deficiency
- Vitamin B12 deficiency
- Hypocalcaemia
- Osteoporosis
Earlier product information also describes use for increasing calcium intake in children and during dentition and periods in which nutritional status may increase the need for these nutrients.
The older wording referring broadly to "retarded convalescence, asthenia, anorexia and debility" should be regarded as historical product-label language rather than interpreted as evidence that the product independently treats the underlying causes of these conditions.
Similarly, the statement regarding "allergic conditions" should not be interpreted as establishing Decal B12-N as an antiallergic treatment.
12. Administration
Route: Oral.
The available regulatory leaflet states that Decal B12 Syrup is administered orally according to the physician's instructions.
The older product information specifies that the syrup may be taken with milk or water or directly from the spoon.
Dosage information
The available regulatory product leaflet specifies:
- 6 months–1 year: 2.5 mL once daily.
- Older than 1 year: 5 mL once daily.
The physician determines the appropriate duration of treatment.
Important: These doses should not be generalized to every current Egyptian presentation without checking the current package leaflet. The original text supplied in the question gives different age-based doses, so the two dosing schemes should not be merged.
13. Method of Preparation
No preparation or reconstitution is required.
The product is supplied as a ready-to-use oral syrup.
For accurate administration, a calibrated oral measuring device should preferably be used rather than relying on an ordinary household teaspoon.
No evidence was found requiring dilution before administration. The older product information states that it may be administered with milk or water or directly from the spoon.
14. Contraindications
The available regulatory information lists the following contraindications/conditions in which the product should not be used:
- Hypersensitivity to the active ingredients or other product components.
- Hypercalcaemia.
- Hypercalciuria.
- Kidney disease/renal disorders as specified in the product information.
- Kidney stones.
- Leber's disease.
The regulatory leaflet also identifies metastatic calcification and anaphylactic/sensitivity reactions in its earlier professional information.
Because terminology and labeling can vary between editions, the current package leaflet should be consulted for the exact contraindication wording of the Egyptian-market pack.
15. Warnings & Precautions
Particular caution is appropriate in:
- Renal impairment: vitamin D and calcium can affect calcium/phosphate balance; prolonged treatment may require monitoring of renal function and serum calcium.
- History of kidney stones or hypercalciuria: additional calcium/vitamin D may increase the risk of calcium-related complications.
- Sarcoidosis and some granulomatous disorders: vitamin D metabolism may be altered, potentially increasing calcium levels.
- Long-term therapy: monitoring of serum calcium and renal function may be appropriate depending on dose, duration, and patient risk factors.
- Immobilized patients with osteoporosis: increased risk of hypercalcaemia may warrant caution.
- Infants: accurate measurement of the dose is particularly important.
Avoid unnecessary simultaneous use of multiple calcium- or vitamin-D-containing products unless advised by a healthcare professional because cumulative intake can increase the risk of excessive calcium or vitamin D exposure.
16. Drug Interactions
Important interactions described in the available product information include:
- Tetracyclines and fluoroquinolones: calcium can reduce gastrointestinal absorption; administration should be separated according to the specific medicine's instructions.
- Bisphosphonates: calcium may reduce absorption; separation of administration is recommended.
- Levothyroxine: calcium can reduce levothyroxine absorption; the doses should generally be separated by at least 4 hours.
- Iron salts and sodium fluoride: calcium can reduce absorption; separation is recommended.
- Thiazide diuretics: reduced urinary calcium excretion can increase the risk of hypercalcaemia.
- Systemic corticosteroids: may reduce calcium absorption and interfere with calcium/vitamin D effects.
- Phenytoin, barbiturates and certain antiepileptics: may increase vitamin D metabolism and reduce its effect.
- Cholestyramine and liquid paraffin: may reduce gastrointestinal absorption of vitamin D.
- Cardiac glycosides such as digoxin: hypercalcaemia may increase cardiac glycoside toxicity.
- Neomycin: may reduce gastrointestinal absorption of vitamin B12.
- Rifampicin and isoniazid: may reduce vitamin D effectiveness according to the product information.
- Oral contraceptives: may alter serum vitamin B12 concentrations.
- Omeprazole: prolonged acid suppression can impair vitamin B12 absorption/status.
The interaction profile should be interpreted in the context of the actual dose and duration of Decal B12-N and the specific concomitant medicine.
17. Side Effects
The available regulatory product information reports:
Gastrointestinal effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain/discomfort
- Constipation
- Flatulence or abdominal distension
Metabolic effects
- Hypercalcaemia
- Hypercalciuria
These are particularly relevant with excessive intake or prolonged use in susceptible individuals.
Hypersensitivity reactions
Rare reactions may include:
- Rash
- Pruritus
- Urticaria
- Angioedema
- Laryngeal oedema
- Very rarely, severe hypersensitivity/anaphylactic reactions
Vitamin B12 hypersensitivity is uncommon but has been reported.
Severe allergic symptoms, especially facial/throat swelling or difficulty breathing, require urgent medical attention.
18. Use in Special Populations
Infants and Children
The product has historically been used in children, including during dentition. However, pediatric dosing should follow the current product labeling or a healthcare professional's instructions. Accurate measurement is particularly important in infants.
Pregnancy
The available regulatory leaflet states that the product may be used during pregnancy when calcium and vitamin D deficiency is present. Use should nevertheless be based on the individual's nutritional requirements and healthcare professional advice.
Breastfeeding
The regulatory information states that calcium/cholecalciferol may be used during breastfeeding. The need for supplementation and total daily intake should be considered when other vitamin/mineral products are being used.
Renal Impairment
Use requires caution because calcium and vitamin D can affect calcium/phosphate homeostasis. Monitoring may be required in patients with significant renal impairment.
Older Adults
No age-specific pharmacokinetic restriction was identified in the available product information. However, older adults may have increased risk of osteoporosis, vitamin D deficiency, renal impairment, or drug interactions, so treatment should be individualized.
19. Storage Conditions
The available regulatory information specifies:
Store below 30°C.
Keep the bottle tightly closed and out of the reach of children.
Do not use after the expiry date stated on the package.
The exact current Egyptian storage wording should be confirmed against the package/leaflet supplied with the marketed bottle.
20. Additional Sections
Product appearance
The available regulatory description states that the syrup is a clear, bright-red solution with a fruity flavor.
Excipients reported in the regulatory leaflet
The available leaflet lists:
- Sucrose
- Sodium methyl parahydroxybenzoate
- Sodium propyl parahydroxybenzoate
- Ethanol
- Glycerin
- Hydrochloric acid
- Poloxamer 407
- Butylated hydroxyanisole
- Potassium sorbate
- Tutti-frutti flavor
- Ponceau 4R color
- Purified water
Shelf life
The available professional product information reports a 2-year shelf life. The expiry date printed on the specific package should always take precedence.
Regulatory/formulation note
A significant discrepancy was identified during verification:
- Regulatory/product-leaflet sources identify the calcium component as calcium levulinate.
- Several current Egyptian commercial listings identify it as calcium gluconate.
The available evidence does not establish that the formulation was officially changed from calcium levulinate to calcium gluconate. Therefore, this article should not state calcium gluconate as an unquestionable fact for the current Egyptian pack unless it has been verified directly from the current Egyptian package, manufacturer leaflet, or official Egyptian regulatory record.
21. Frequently Asked Questions (FAQ)
What is Decal B12-N Syrup used for?
It is a calcium, vitamin D3, and vitamin B12 preparation used for nutritional deficiency-related indications involving these nutrients. The available regulatory information specifically includes vitamin D deficiency, vitamin B12 deficiency, hypocalcaemia, and osteoporosis.
What are the active ingredients?
The available regulatory leaflet identifies calcium levulinate, cholecalciferol (vitamin D3), and cyanocobalamin (vitamin B12).
How much is contained in 5 mL?
According to the available regulatory composition:
- Calcium levulinate 50 mg
- Vitamin D3 1,000 IU
- Vitamin B12 10 mcg.
Is Decal B12 an antibiotic?
No. It is not an antimicrobial medicine.
Can children take Decal B12-N?
The product has pediatric use in its labeling. The available regulatory leaflet specifies 2.5 mL once daily for children aged 6 months to 1 year and 5 mL once daily for children older than 1 year. The current package leaflet should be checked before applying these doses to a specific patient.
Can it be taken with milk?
Older product information states that the syrup can be taken with milk or water or directly from the spoon.
Can it be taken during pregnancy?
The available regulatory leaflet states that it can be used during pregnancy in cases of calcium and vitamin D deficiency. Individual medical advice remains appropriate because total calcium and vitamin D intake from all sources must be considered.
Can it be used during breastfeeding?
The available regulatory information states that calcium/cholecalciferol can be used during breastfeeding.
What happens if too much is taken?
Excessive calcium/vitamin D exposure can cause hypercalcaemia and related complications. Accidental or excessive ingestion, particularly in children, warrants prompt contact with a healthcare professional or poison-information service.
Does Decal B12-N have drug interactions?
Yes. Calcium and vitamin D can interact with several medicines, including levothyroxine, tetracyclines, quinolones, bisphosphonates, iron salts, thiazide diuretics, and cardiac glycosides. Vitamin B12 absorption can also be affected by certain medicines.
How should it be stored?
The available regulatory information specifies storage below 30°C and keeping it out of reach of children.
22. References
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Saudi Food and Drug Authority (SFDA) — Saudi Drug Information System: DECAL B12 Syrup. Regulatory product information including composition, indications, contraindications, interactions, dosage, adverse effects, storage, manufacturer, and leaflet revision history. The available record identifies Amriya Pharmaceutical Industries and a leaflet revision dated 14/04/2019.
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MedicineP — Decal B12 Syrup product information: historical product information documenting the 100 mL composition equivalent to 50 mg calcium levulinate, 1,000 IU vitamin D3, and 10 mcg vitamin B12 per 5 mL, together with historical indications, dosing, interactions, and storage information.
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Egyptian-market listing — Decal B12-N Syrup 120 mL: current commercial listing identifying the product as an Amriya 120 mL syrup and providing the GTIN 6221075051184.
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Egyptian drug-price/database listing — Decal B12-N Syrup 120 mL: current market-index information identifying the trade name, manufacturer (Amriya), 120 mL presentation, and a calcium gluconate + vitamin D3 + vitamin B12 description. This source is treated as market evidence, not as definitive regulatory confirmation of the formulation.
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Egyptian pharmacy listing: current listing of DECAL B12-N Syrup 120 mL identifying the product with calcium levulinate in its displayed product name.
Verification conclusion
The strongest verifiable product evidence supports DECAL B12 Syrup/N Syrup 120 mL manufactured by Amriya, with vitamin D3 1,000 IU and vitamin B12 10 mcg per 5 mL. The principal unresolved issue is the calcium salt: the available regulatory leaflet states calcium levulinate 50 mg/5 mL, whereas several current Egyptian commercial databases state calcium gluconate. Because this difference cannot be reliably resolved from secondary market listings alone, the scientifically safest wording is to retain calcium levulinate when citing the available regulatory leaflet and explicitly flag the current Egyptian-market formulation discrepancy rather than inventing a formulation change.