Label: DIGESTIVE RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid
- NDC Code(s): 11673-372-08, 11673-372-16
- Packager: TARGET 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 July 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
-
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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
Ask a doctor or pharmacist before use if you are
taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
-
Directions
- shake well before using
- mL = milliliter
- measure only with dosing cup provided. do not use any other dosng device.
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
- Questions?
-
Principal Display Panel
Compare to the active ingredient in Pepto-Bismol® Regular Strength*
5-symptom
digestive relief
Bismuth subsalicylate 525 mg per 30 mL
upset stomach reliever/antidiarrheal
relieves nausea, heartburn, indigestion
upset stomach and diarrhea
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Dist. by Target Corp.,
Mpls., MN 55403
- Package Label
-
INGREDIENTS AND APPEARANCE
DIGESTIVE RELIEF REGULAR STRENGTH
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 525 mg in 30 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-372-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2018 2 NDC:11673-372-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 07/31/2018 Labeler - TARGET Corporation (006961700)
