Your browser does not support JavaScript! UPSET STOMACH RELIEF TO GO (BISMUTH SUBSALICYLATE) POWDER [BREAKTHROUGH PRODUCTS INC.]
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UPSET STOMACH RELIEF TO GO (bismuth subsalicylate) powder
[Breakthrough Products Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

Active ingredient (per powder)

Bismuth subsalicylate 525mg

Purposes

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 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 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 above 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 table contains salicylate 242mg

Inactive ingredients

citric acid, flavor, glucose, silica, sucralose

Questions?

1-888-99-URGENT (Mon-Fri 9AM-5PM MDT)

Do not use if pouch
is torn or open

distributed by
URGENT Rx®

Breakthrough Products, Inc.
Denver, CO 80202

PRINCIPAL DISPLAY PANEL - Pouch Label

New!

RIGHT
NOW
RELIEF

No Liquid Required
FAST POWDERS
Pour Directly In Mouth

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

Principal Display Panel - Pouch Label
UPSET STOMACH RELIEF TO GO 
bismuth subsalicylate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51596-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth subsalicylate (SALICYLIC ACID and BISMUTH CATION) Bismuth subsalicylate525 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
dextrose 
silicon dioxide 
sucralose 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51596-004-055 in 1 BOX
1NDC:51596-004-011 in 1 POUCH
2NDC:51596-004-1212 in 1 BOX
2NDC:51596-004-011 in 1 POUCH
3NDC:51596-004-2424 in 1 BOX
3NDC:51596-004-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33509/01/2011
Labeler - Breakthrough Products Inc. (962008251)

Revised: 11/2013
 
Breakthrough Products Inc.

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