| NDC | 41167-3330-1, 41167-3330-3, 41167-7449-2 |
| Set ID | 9e64b4bf-94f1-4d80-a635-c445b1494a0a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Chattem, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART335 |
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- 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 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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
- allergic to salicylates (including aspirin)
-
Directions
-
shake well immediately before each use
- adults and children 12 years of age and older: 30 mL or 2 tablespoonfuls
- 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
-
shake well immediately before each use
- Other Information
- Inactive Ingredients
- Active Ingredient
- Purpose
- 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 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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
- allergic to salicylates (including aspirin)
-
Directions
-
shake well immediately before each use
- adults and children 12 years of age and older: 30 mL or 2 tablespoonfuls
- for accurate dosing, use convenient pre-measured dose cup
- repeat dose every hour as needed
- do not exceed 4 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
-
shake well immediately before each use
- Other Information
- Inactive Ingredients
- Principal Display Panel
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
KAOPECTATE REGULAR STRENGTH PEPPERMINT FLAVOR ANTI DIARRHEAL
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-3330 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 17.47 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (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 PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-3330-1 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2003 2 NDC:41167-3330-3 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 04/01/2003 KAOPECTATE EXTRA STRENGTH PEPPERMINT FLAVOR ANTI DIARRHEAL
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-7449 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 35.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (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 PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-7449-2 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 04/01/2003 Labeler - Chattem, Inc. (003336013)
