Label: MEDI-FIRST PEP-T-MED- bismuth subsalicylate tablet, chewable
- NDC Code(s): 47682-406-20, 47682-406-69
- Packager: Unifirst First Aid Corporation
- 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 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 occur, 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 salicylates (including aspirin)
- taking other salicylate products
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- chew or dissolve in mouth
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Adults and children: (12 years and over)
- chew 2 tablets every 1/2 to 1 hour as needed
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops, but not more than 2 days
Children under 12 years: Ask a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Medi-First Pep-T-Med Label
36 Chewable Tablets
Medi-First®
PEP-T-MED
Chewable Tablets
Compare active ingredients to:
Pepto Bismol®
Registered Trademark of Proctor & Gamble
Upset Stomach/Diarrhea Relief • Bismuth Subsalicylate 262mg
Chew or crush tablets completely before swallowing.
Do not swallow tablets whole.
Tamper Evident
-
INGREDIENTS AND APPEARANCE
MEDI-FIRST PEP-T-MED
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-406 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 ASPARTAME (UNII: Z0H242BBR1) CALCIUM CARBONATE (UNII: H0G9379FGK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ACACIA (UNII: 5C5403N26O) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor PEPPERMINT Imprint Code RH;046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-406-20 6 in 1 BOX 12/01/2011 1 NDC:47682-406-69 6 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 part335 12/01/2011 Labeler - Unifirst First Aid Corporation (832947092)