Label: KAOPECTATE CHERRY FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid
- NDC Code(s): 55505-201-36
- Packager: Kramer Laboratories
- 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 December 16, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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 and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
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
- only use pre-measured dose cup
- adults and children 12 years of age and older:
- 1 dose (30 mL) every ½ hour to 1 hour as needed.
- 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
Principal Display Panel
• Anti-Diarrheal • Upset Stomach Reliever
✓ Begins controlling symptoms from the first dose
✓ Quickly relieves urgency, gas, and cramping
✓ Effective on diarrhea from bacteria, viruses, and other causes
8 fl oz (236 mL)
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
INGREDIENTS AND APPEARANCE
KAOPECTATE CHERRY FLAVOR ANTI DIARRHEAL
bismuth subsalicylate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bismuth Subsalicylate (UNII: 62TEY51RR1) (Bismuth Cation - UNII:ZS9CD1I8YE) Bismuth Subsalicylate 262 mg in 15 mL Inactive Ingredients Ingredient Name Strength Caramel (UNII: T9D99G2B1R) Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) Fd&C Red No. 40 (UNII: WZB9127XOA) Microcrystalline Cellulose (UNII: OP1R32D61U) Sodium Salicylate (UNII: WIQ1H85SYP) Sorbic Acid (UNII: X045WJ989B) Sucrose (UNII: C151H8M554) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55505-201-36 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 11/01/2020 Labeler - Kramer Laboratories (122720675) Establishment Name Address ID/FEI Business Operations Trillium Health Care Products Inc. 255426306 manufacture(55505-201)