FDA Label for Regular Strength Stomach Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- 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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Regular Strength Stomach Relief Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp, Inc.. 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.
Otc - Active Ingredient
Active ingredient (in each tablet)
Bismuth subsalicylate 262 mg
Otc - Purpose
Purpose
Upset stomach reliever and antidiarrheal
Indications & Usage
Uses relieves
travelers' diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
o heartburn
o indigestion
o nausea
o gas
o belching
o fullness
Warnings
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
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 (1-800-222-1222).
Dosage & Administration
Directions
chew or dissolve in mouth
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 overindulgence (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 of clear fluids to help prevent dehydration caused by diarrhea
Other Safety Information
Other information
- each tablet contains: calcium 140 mg
- salicylate 101 mg
- low sodium
- avoid excessive heat (over 104°F or 40°C)
Inactive Ingredient
Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
Otc - Questions
Questions or comments?
call 1-877-290-4008
Package Label.Principal Display Panel
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