Label: REGULAR STRENGTH PINK BISMUTH- bismuth subsalicylate suspension
- NDC Code(s): 69842-766-12
- Packager: CVS PHARMACY, 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 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(in each 30 mL dose cup)
- Purposes
- Uses
-
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
- ▪
- 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)
- ▪
- diabetes
- ▪
- gout
- ▪
- arthritis
-
Directions
- ▪
- shake well before use
- ▪
- only use dose cup provided
- ▪
- adults and children 12 years and over: (30 mL) 1 dose every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
- ▪
- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- ▪
- 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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
NDC# 69842-766-12
Compare To the active ingredient in Pepto-Bismol® Regular Strength
Regular Strength
Pink Bismuth
Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal
Relieves:
- •
- Nausea
- •
- Heartburn
- •
- Indigestion
- •
- Upset Stomach
- •
- Diarrhea
Cherry Flavor
Naturally and Artificially Flavored
12 FL. OZ. (354 mL)
CVS® Quality
Money Back Guarantee
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com 1-800-SHOP CVS
V-16415
*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol® Regular Strength.
-
INGREDIENTS AND APPEARANCE
REGULAR STRENGTH PINK BISMUTH
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-766 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 CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-766-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 09/25/2019 Labeler - CVS PHARMACY, INC. (062312574)