FDA Label for Prenatal Plus Iron
View Indications, Usage & Precautions
Prenatal Plus Iron Product Label
The following document was submitted to the FDA by the labeler of this product Blenheim Pharmacal, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.
Each Prenatal Plus tablet Contains:
Vitamin A (Acetate and Beta Carotene)............................................4000 I.U.
Vitamin C (Ascorbic acid)..................................................................120 mg
Vitamin D-3 (Cholecalciferol)...............................................................400 I.U.
Vitamin E (dl- Alpha Tocopheryl Acetate)...........................................22 I.U.
Thiamine (Vitamin B-1 from Thiamine Mononitrate...............................1.84 mg
Riboflavin (Vitamin B-2).......................................................................3 mg
Niacin(Niacinamide).............................................................................20 mg
Vitamin B-6 (Pyridoxine HCl)...............................................................10 mg
Folic Acid.............................................................................................1 mg
Vitamin B-12 (Cyanocobalamin)..........................................................12 mcg
Calcium (Calcium Carbonate)...............................................................200 mg
Iron (Carbonyl Iron)..............................................................................29 mg
Zinc (Zinc Oxide).................................................................................25 mg
Copper (Cupric Oxide)..........................................................................2 mg
Other ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow # 5 lake, FD&C Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate
Indications
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception
Dosage
As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.
Warning
Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Precautions: Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Storage
Store at room temperature. Dispense in a well closed light resistant container with a child resistant cap.
How Supplied
NDC 0904-5339-60 plastic bottle containing 100 Tablets.
Principal Display Panel
Prenatal Plus Iron Tablets (Multivitamin/Multimineral Supplement)
31 Tabets
10544-609-31
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