FDA Label for Upset Stomach Relief To Go
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (PER POWDER)
- PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 1 POWDER PACKET
Upset Stomach Relief To Go Product Label
The following document was submitted to the FDA by the labeler of this product Breakthrough Products 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.
Other
Drug Facts
| Do not use if pouch is torn or open |
distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202
Active Ingredient (Per Powder)
Bismuth subsalicylate 525mg
Purpose
Upset stomach reliever/antidiarrheal
Uses
Relieves:
- traveler's diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
Reye's Syndrome
Children and teenagers who have or are recovering from chickenpox 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.
Otc - Do Not Use
Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
- an ulcer
- a bleeding problem
- bloody or black stool
Do not use if you have
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.
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 for 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.
Directions
adults and children 12 years and over:
- see instructions in red box for opening packet
- place 1 powder on the tongue and swallow with or without water every ½ to 1 hour as needed
- do not exceed 8 doses 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 dose contains salicylate 199mg
Inactive Ingredients
citric acid, flavor, glucose, silica, sucralose
Questions?
1-888-998-7436 (Mon-Fri 9AM-5PM MDT)
Principal Display Panel - 1 Powder Packet
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WATER
REQUIRED
POUR DIRECTLY IN MOUTH
URGENT Rx®
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POWDERS™
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UPSET
STOMACH
URGENT Rx®
RELIEF
TO-GO™
BISMUTH SUBSALICYLATE/
UPSET STOMACH RELIEVER & ANTIDIARRHEAL
cherry
distributed by UrgentRx
1 POWDER PACK
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