Label: ANTI-DIARRHEAL- bismuth subsalicylate tablet
- NDC Code(s): 66715-6841-4
- Packager: Lil' Drug Store Products, 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 March 11, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
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.
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 of 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
- swallow caplet(s) with water, do not chew
- adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
- do not take more than 8 doses (16 caplets) 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 262 mg Caplet Bottle Carton
INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6841 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bismuth Subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) Bismuth Subsalicylate 262 mg Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) Magnesium Stearate (UNII: 70097M6I30) Mannitol (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Polysorbate 80 (UNII: 6OZP39ZG8H) Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B) Product Characteristics Color PINK Score no score Shape OVAL Size 16mm Flavor Imprint Code G172 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6841-4 1 in 1 CARTON 02/21/2019 1 24 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 02/21/2019 Labeler - Lil' Drug Store Products, Inc. (093103646)