Label: STOMACH RELIEF- bismuth subsalicylate liquid
- NDC Code(s): 0121-0910-30, 0121-0910-40
- Packager: PAI Holdings, LLC
- 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 7, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL dose )
- Purpose
- Uses
-
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
Ask a doctor or pharmacist before use if you are
taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
-
Directions
- mL = milliliter
- shake well before using
- only use dose ready dosing cup provided. Do not use any other dosing device
- 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 diarrhea/traveler's diarrhea
- 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL ) in 24 hours
- use until diarrhea stop but not more than 2 days
- children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration cause by diarrhea
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
STOMACH RELIEF
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0910 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) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color pink Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0910-40 4 in 1 CASE 07/17/2020 1 10 in 1 TRAY 1 NDC:0121-0910-30 30 mL in 1 CUP, UNIT-DOSE; 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 07/17/2020 Labeler - PAI Holdings, LLC (044940096) Establishment Name Address ID/FEI Business Operations PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 097630693 label(0121-0910) , manufacture(0121-0910)
