Label: TROPICAL PANNED- calcium carbonate, simethicone tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 52642-230-54 - Packager: BestCo Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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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- 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, FD&C red #40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methly paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glyclol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, water, white wax
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INGREDIENTS AND APPEARANCE
TROPICAL PANNED
calcium carbonate, simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52642-230 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 DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color pink Score score with uneven pieces Shape ROUND Size 70mm Flavor TROPICAL FRUIT PUNCH Imprint Code AS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52642-230-54 54 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 10/02/2015 Labeler - BestCo Inc. (002149136) Registrant - Bayer (112117283) Establishment Name Address ID/FEI Business Operations BestCo Inc. 002149136 manufacture(52642-230)