Label: SOOTHE- bismuth subsalicylate tablet
- NDC Code(s): 0363-0346-10
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 12, 2015
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- Active ingredient (in each caplet)
Bismuth subsalicylate 262 mgClose
Upset stomach reliever/AntidiarrhealClose
- travelers' diarrhea
- upset stomach due to overindulgence in food and drink, including:
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 of the blood)
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 1/2 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
- each caplet contains: calcium 20 mg, salicylate 103 mg
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid excessive heat
- see end flap for expiration date and lot number
- Inactive ingredients
calcium carbonate, D&C red #27 aluminium lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acidClose
- Questions or comments?
- Principal Display Panel
WALGREENS PHARMACIST RECOMMENDEDǂ
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever / Antidiarrheal
Multi-symptom relief of:
• Nausea • Heartburn
• Upset stomach
Compare to Pepto-Bismol®
ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2012 Walgreen Co.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0346 Route of Administration ORAL DEA Schedule 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 D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) CALCIUM CARBONATE (UNII: H0G9379FGK) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color PINK Score no score Shape OVAL Size 15mm 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 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 CO. (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0346) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0346)