FDA Label for Rite Aid Stomach Relief Original Flavor
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING ANY DRUG FOR
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY
Rite Aid Stomach Relief Original Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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.
Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and antidiarrheal
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 stool
Ask A Doctor Before Use If You Have
▪ fever▪ mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are Taking Any Drug For
▪ anticoagulation (thinning of the blood)▪ diabetes▪ gout▪ arthritis
When Using This Product
a 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
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222
Directions
▪ chew completely or dissolve tablets in mouth. Do not swallow tablets whole.▪ adults and children 12 years and over:▪ 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea▪ 2 tablets (1 dose) every ½ hour as needed for over indulgence (upset stomach, heartburn, indigestion, nausea.▪ do not exceed 8 doses (16 tablets) in 24 hours▪ use until diarrhea stops but not more than 2 days▪ children under 12 years: ask a doctor▪ drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Other Information
▪ each tablet contains: salicylate 102 mg▪ store at room temperature.▪ avoid excessive heat
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
Inactive Ingredients
D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display
NDC# 11822-2430-0
Compare to the active ingredient in Pepto-Bismol® Chewables*
Stomach Relief
Chewable Tablets
Bismuth Subsalicylate
Upset Stomach Reliever / Antidiarrheal
5 Symptoms Digestive Relief:
• Heartburn• Indigestion• Nausea• Upset Stomach• Diarrhea
Original Flavor
30 Chewable Tablets
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
SATISFACTION GUARANTEE
If you’re not satisfied, we will happily refund your money.
IMPORTANT: Keep this carton for future labeling. |
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol® Chewables.
* Please review the disclaimer below.