Label: DRX CHOICE STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate suspension
- NDC Code(s): 68163-707-12
- Packager: RARITAN PHAMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
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 September 2, 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:
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- 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
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- 15 mL (1 dose) every ½ hour as needed 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
DRx Choice®
NDC# 68163-707-12
Compare to the active ingredient in Pepto-Bismol® Ultra Strength
Ultra strength
Pink bismuth
Bismuth Subsalicylate /
Upset Stomach Reliever/Antidiarrheal
Original Flavor
Naturally and Artificially Flavored
Relieves:
Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea
12 FL. OZ. (354 mL)
Manufactured by: Raritan Pharmaceuticals
8 Joanna Court
East Brunswick
NJ 08816
*This product is not manufactured or distributed by The Procter & Gamble Co., owner of the registered trademark Pepto-Bismol®.
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INGREDIENTS AND APPEARANCE
DRX CHOICE STOMACH RELIEF REGULAR STRENGTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-707 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:68163-707-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 12/06/2021 Labeler - RARITAN PHAMACEUTICALS INC (127602287)