Label: STOMACH RELIEF- bismuth subsalicylate suspension
- NDC Code(s): 37012-302-40
- Packager: Shopko Stores Operating Co., 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.
Updated June 14, 2016
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- Active ingredient (in each 30 mL)
Bismuth subsalicylate 525 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 1/2 to 1 hour as needed
- do not exceed 8 doses (240 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 254 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 Pepto-Bismol® Active Ingredient
525 mg per 30 mL
Upset Stomach Reliever/Antidiarrheal
5 Symptom Relief Of:
12 FL OZ (354 mL)Close
- INGREDIENTS AND APPEARANCE
bismuth subsalicylate suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-302 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 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) XANTHAN GUM (UNII: TTV12P4NEE) 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:37012-302-40 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 11/14/2013 Labeler - Shopko Stores Operating Co., LLC (023252638)