Label: REGULAR STRENGTH PINK BISMUTH- bismuth subsalicylate suspension
- NDC Code(s): 68163-706-04, 68163-706-12
- Packager: Raritan Pharmaceuticals Inc
- 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 September 2, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 30 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: (30 mL) 1 dose every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
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- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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- do not exceed 8 doses (240 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# 68163-706-04
*Compare to the active ingredient Pepto-Bismol® Regular Strength
Regular Strength
Pink Bismuth
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
Relieves nausea, heartburn, indigestion, upset stomach, diarrhea
ORIGINAL FLAVOR
4 FL. OZ. (118 mL)
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.
*This product is not manufactured or distributed by The Procter & Gamble, distributor of Pepto-Bismol® Regular Strength.
Package Label for 118 mL
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INGREDIENTS AND APPEARANCE
REGULAR STRENGTH PINK BISMUTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-706 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 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:68163-706-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2019 2 NDC:68163-706-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 05/13/2019 Labeler - Raritan Pharmaceuticals Inc (127602287)
