Label: FIRST AID DIRECT PEPTUM TABS- bismuth subsalicylate tablet, chewable
- NDC Code(s): 42961-109-01, 42961-109-02
- Packager: Cintas Corp
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occurs, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Contains salicylate. Do not take if you are
- allergic to salicylate (including asprin)
- taking other salicylate products
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
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Directions
- chew or dissolve in mouth
- Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
- 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 tablets) in 24 hours
- use until diarrhea stops but not more than 2 days
- Children under 12: ask a doctor
- drink plenty of fluids to help prevent dehydration which may accompany diarrhea
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel - Box
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INGREDIENTS AND APPEARANCE
FIRST AID DIRECT PEPTUM TABS
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-109 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ASPARTAME (UNII: Z0H242BBR1) CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor Imprint Code RH046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-109-02 30 in 1 BOX 10/25/2021 1 NDC:42961-109-01 1 in 1 CELLO PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 10/25/2021 Labeler - Cintas Corp (056481716) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 manufacture(42961-109)