- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
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 salicytate products
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- shake well before use
- for accurate dosing, use dose cup
- adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
- do not exceed 8 doses (16 Tbsp or 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY CARE STOMACH RELIEF
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-626 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 1050 mg in 30 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSES (UNII: 3NXW29V3WO) MENTHOL (UNII: L7T10EIP3A) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-626-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 07/31/2015 Labeler - United Exchange Corp. (840130579)