Label: BISMUTH SUBSALICYLATE capsule, liquid filled
- NDC Code(s): 79481-0057-2
- Packager: MEIJER DISTRIBUTION, INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 9, 2024
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- Drug Facts
- Active ingredient (in each softgel) Bismuth subsalicylate 262 mg
- Purpose Upset stomach reliever and anti-diarrheal
- Uses relieves • travelers' diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness
- 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
- Do not Use if you have • an ulcer • a bleeding problem • bloody or black stoo
- Ask a doctor before use if you have • fever • mucus in the stool
- Ask a doctor or pharmacist before use if you aretaking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis
- When using this producta temporary, but harmless, darkening of the stool and/or tongue may occur
- Stop use and ask a doctor if • symptoms get worse or last more than 2 days • ringing in the ears or loss of hearing occurs • diarrhea lasts more than 2 days
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions • swallow with water, do not chew • adults and children 12 years and over: • 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea • 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) 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 each softgel contains:salicylate 102 mg • very low sodium • do not exceed 25°C
- Inactive ingredients aerosil, beeswax, D&C Red#33, FD&C Yellow-6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxy methyl cellulose, sorbitol sorbitan solution, soya lecithin, titanium dioxide
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INGREDIENTS AND APPEARANCE
BISMUTH SUBSALICYLATE
bismuth subsalicylate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0057 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PARAFFIN (UNII: I9O0E3H2ZE) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SORBITOL SOLUTION (UNII: 8KW3E207O2) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape OVAL Size 21mm Flavor Imprint Code 262 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0057-2 2 in 1 CARTON 02/01/2024 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 02/01/2024 Labeler - MEIJER DISTRIBUTION, INC. (006959555)
