Label: ORANGE ANTACID SOFTCHEW- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 52642-021-32 - 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 March 14, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain perscription drugs.
Do not take more than 6 chews in a 34-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORANGE ANTACID SOFTCHEW
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52642-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 1177 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color orange Score no score Shape RECTANGLE Size 22mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52642-021-32 32 in 1 BAG; Type 0: Not a Combination Product 03/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 03/14/2014 Labeler - BestCo Inc. (002149136) Registrant - BestCo Inc. (002149136) Establishment Name Address ID/FEI Business Operations BestCo Inc. 002149136 manufacture(52642-021)