Label: FIRST AID ONLY ANTACID- calcium carbonate tablet, chewable
- NDC Code(s): 0924-0286-01
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 47682-088
- 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 28, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor or pharmacist before use if you are
- taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
- do not take more than 19 tablets in 24 hours
- do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician
- do not exceed recommended dosage
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments
- Principal Display Panel - First Aid Only Antacid Tablets
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0286(NDC:47682-088) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 420 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor MINT (MINT) Imprint Code FR;8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0286-01 20 in 1 BOX, UNIT-DOSE 03/28/2018 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/30/2008 Labeler - Acme United Corporation (001180207) Registrant - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-0286) , repack(0924-0286) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-0286) , repack(0924-0286)
