Label: SOOTHE- bismuth subsalicylate tablet
- NDC Code(s): 0363-0346-10
- Packager: Walgreen Company
- 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 January 3, 2022
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- Active ingredient (in each caplet)
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
- 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
- swallow with water; do not chew
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
- use until diarrhea stops, but not more than 2 days
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Compare to Pepto-Bismol®
BISMUTH SUBSALICYLATE 262 mg /
UPSET STOMACH RELIEVER /
• Multi-symptom relief of nausea, heartburn,
indigestion, upset stomach & diarrhea
you rely on,
quality you trust.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†Walgreens Pharmacist Survey
†† This product is not manufactured or
distributed by Procter & Gamble,
owner of the registered trademark
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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walgreens.com ©2017 Walgreen Co.
INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0346 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) CALCIUM CARBONATE (UNII: H0G9379FGK) MANNITOL (UNII: 3OWL53L36A) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color pink Score no score Shape OVAL Size 16mm Flavor Imprint Code 44;346 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0346-10 1 in 1 CARTON 05/06/2011 1 40 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 05/06/2011 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0363-0346) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0363-0346) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0363-0346) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0363-0346)