FDA Label for Walgreen
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Walgreen Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Allergy alert: Contains salicylates.Do not take if you are:
▪ allergic to salicylates (including aspirin)▪ taking other salicylate products
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.
*Walgreen Pharmacist Recommended Walgreens Pharmacist Survey.
††This 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 © 2018 Walgreen Co.
Active Ingredient (In Each Chewable Tablet)
Bismuth subsalicylate 262 mg
Purpose
Anti-diarrheal / upset stomach reliever
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.
Otc - Do Not Use
Do not use if you have
▪ an ulcer▪ a bleeding problem▪ bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
▪ fever▪ mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
▪ anticoagulation (thinning the blood)▪ diabetes▪ gout▪ arthritis
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ chew or dissolve tablet in mouth▪ adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed.Do not exceed 8 doses (16 tablets) in 24 hours.
▪ use until diarrhea stops, but not more than 2 days▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea▪ children under 12 years: ask a doctor
Other Information
▪ each tablet contains: salicylate 102 mg▪ store at room temperature▪ avoid excessive heat
Inactive Ingredients
flavor, magnesium stearate, maltodextrin, microcrystalline, cellulose, red #27 (Al-lake), sorbitol, sucralose.
Questions Or Comments?
Call 1-866-467-2748
Package Label.Principal Display Panel
NDC 0363-9124-30
Walgreens
Soothe®
BISMUTH SUBSALICYLATE, 262 MG
UPSET STOMACH RELIEVER / ANTI-DIARRHEAL
30 CHEWABLE TABLETS
Multi-symptom relief of nausea, heartburn, indigestion, upset stomach & diarrhea
*Compare to Pepto-Bismol® active ingredient††
* Please review the disclaimer below.