UPSET STOMACH RELIEF TO GO- bismuth subsalicylate powder

Upset Stomach Relief to Go by

Drug Labeling and Warnings

Upset Stomach Relief to Go by is a Otc medication manufactured, distributed, or labeled by Breakthrough Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

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.

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 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 for more than 2 days

If pregnant or breast-feeding, ask a health professional before use.

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)

SPL UNCLASSIFIED SECTION

Do not use if pouch
is torn or open

distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202

PRINCIPAL DISPLAY PANEL - 1 Powder Packet

New!

NO
WATER
REQUIRED
POUR DIRECTLY IN MOUTH

URGENT Rx®
FAST
POWDERS™

◀ SEE OPENING INSTRUCTIONS ON BACK PANEL ▶

UPSET
STOMACH

URGENT Rx®

RELIEF
TO-GO™

BISMUTH SUBSALICYLATE/
UPSET STOMACH RELIEVER & ANTIDIARRHEAL

cherry

distributed by UrgentRx
1 POWDER PACK

INGREDIENTS AND APPEARANCE

UPSET STOMACH RELIEF TO GO 
bismuth subsalicylate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51596-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bismuth subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	Bismuth subsalicylate	525 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
dextrose (UNII: IY9XDZ35W2)
silicon dioxide (UNII: ETJ7Z6XBU4)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51596-004-05	5 in 1 BOX
1	NDC: 51596-004-01	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 51596-004-12	12 in 1 BOX
2	NDC: 51596-004-01	1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 51596-004-24	24 in 1 BOX
3	NDC: 51596-004-01	1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 51596-004-10	10 in 1 BOX
4		1 in 1 PACKET; 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	09/01/2011

Labeler - Breakthrough Products Inc. (962008251)