Label: ASSORTED FRUIT PANNED- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 52642-228-60 - Packager: BestCo
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 15, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients
acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 (tartrazine), FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methly paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax
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INGREDIENTS AND APPEARANCE
ASSORTED FRUIT PANNED
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52642-228 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color yellow, pink, orange Score score with uneven pieces Shape ROUND Size 70mm Flavor ORANGE, LEMON, STRAWBERRY Imprint Code AS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52642-228-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 08/31/2015 Labeler - BestCo (002149136) Registrant - Bayer (112117283) Establishment Name Address ID/FEI Business Operations BestCo Inc 002149136 manufacture(52642-228)