Label: CVS HEALTH ANTI-DIARRHEAL VANILLA- bismuth subsalicylate suspension
- NDC Code(s): 59779-883-12
- 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.
Updated September 13, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each 15 ml)
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
- shake well immediately before each use
- adults and children 12 years of age and older: 30 ml or 2 tablespoonful
- for accurate dosing, use convenient pre-measured dose cup
- repeat dose every 1/2 hour to 1 hour as needed
- do not exceed 8 doses 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
PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
50% MORE FREE THAN THE 8 OZ NATIONAL BRAND
CVS Health ™
Compare to the active ingredient in Kaopectate®*
Bismuth Subsalicylate, 262 mg
Upset stomach reliever
- Effective diarrhea relief
- Restores natural balance
- Contains Salicylates
12 FL OZ (355 mL)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com® 1-800-SHOP CVS
*This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.
INGREDIENTS AND APPEARANCE
CVS HEALTH ANTI-DIARRHEAL VANILLA
bismuth subsalicylate suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-883 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bismuth subsalicylate (UNII: 62TEY51RR1) (Salicylic acid - UNII:O414PZ4LPZ, Bismuth cation - UNII:ZS9CD1I8YE) Bismuth subsalicylate 262 mg in 15 mL Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) salicylic acid (UNII: O414PZ4LPZ) DIMETHICONE (UNII: 92RU3N3Y1O) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-883-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/11/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 08/11/2015 Labeler - CVS Pharmacy,Inc. (062312574)