Label: TOPCARE STOMACH RELIEF ULTRA STRENGTH- bismuth subsalicylate suspension
- NDC Code(s): 36800-341-08, 36800-341-12
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 15 mL dose)
- Purposes
- Uses
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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 or 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
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- allergic to salicylates (including aspirin)
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- taking other salicylate products
Ask a doctor or pharmacist before use if you are
taking any drug for
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- anticoagulation (thinning the blood)
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- diabetes
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- gout
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- arthritis
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Directions
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- shake well before use
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- Only use dose cup provided
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- adults and children 12 years and over: 15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
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- 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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- do not exceed 8 doses (120 mL) in 24 hours
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- use until diarrhea stops but not more than 2 days
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- children under 12 years: ask a doctor
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- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
TopCare® health™
COMPARE TO PEPTO-BISMOL® ULTRA STRENGTH ACTIVE INGREDIENT*
ULTRA STRENGTH
Stomach Relief
BISMUTH SUBSALICYLATE 525 mg per 15 mL
UPSET STOMACH RELIEVER/ANTIDIARRHEAL
5 SYSMPTOM DIGESTIVE RELIEF
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- Heartburn
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- Indigestion
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- Upset Stomach
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- Nausea
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- Diarrhea
OUR PHARMACISTS RECOMMEND
QUALITY GURANTEED
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO RARA0919
QUESTIONS? 1-888-423-0139
topcare@topco.com, www.topcarebrand.com
*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol®.
Package Label 354 mL
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INGREDIENTS AND APPEARANCE
TOPCARE STOMACH RELIEF ULTRA STRENGTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-341 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 15 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SALICYLIC ACID (UNII: O414PZ4LPZ) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK (viscous) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-341-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2019 2 NDC:36800-341-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 03/14/2019 Labeler - TOPCO ASSOCIATES LLC (006935977)