Label: STOMACH RELIEF- bismuth subsalicylate suspension
- NDC Code(s): 59779-699-34, 59779-699-40
- Packager: CVS Pharmacy
- 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.
Updated September 12, 2016
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- Active ingredient (in each 30 mL)
Bismuth subsalicylate 1050 mgClose
Upset stomach reliever and antidiarrhealClose
- travelers’ diarrhea
- upset stomach due to overindulgence in food and drink, including:
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
- anticoagulation (thinning the blood)
Stop use and ask a doctor if
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
- shake well before use
- only use the dose cup provided
- adults and children 12 years and over: 1 dose (30 mL) every hour as needed
- do not exceed 4 doses (120 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- each 30 mL contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
- salicylate 461 mg
- low sodium
- store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
- protect from freezing
- does not meet USP requirements for pH
- for health information visit www.more-info.info
- Inactive ingredients
D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gumClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient in Pepto-Bismol®
1050 mg PER 30 mL
Upset Stomach Reliever/Antidiarrheal
Soothing relief for 5 symptoms:
8 FL OZ (237 mL)Close
- INGREDIENTS AND APPEARANCE
bismuth subsalicylate suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-699 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 1050 mg in 30 mL Inactive Ingredients Ingredient Name Strength MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) XANTHAN GUM (UNII: TTV12P4NEE) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) METHYL SALICYLATE (UNII: LAV5U5022Y) Product Characteristics Color PINK (viscous) Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-699-34 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2005 2 NDC:59779-699-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/1992 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 06/24/1992 Labeler - CVS Pharmacy (062312574)