Label: UPSET STOMACH RELIEF TO GO- bismuth subsalicylate powder
- Packager: Breakthrough Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (per powder)
Bismuth subsalicylate 525mgClose
Upset stomach reliever/antidiarrhealClose
- traveler's diarrhea
- upset stomach due to overindulgence in food and drink, including:
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.
Ask a doctor or pharmacist before use if you are taking any drug for:
- anticoagulation (thinning the blood)
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 doctorClose
- Other information
each dose contains salicylate 199mgClose
- Inactive ingredients
citric acid, flavor, glucose, silica, sucraloseClose
1-888-998-7436 (Mon-Fri 9AM-5PM MDT)Close
- SPL UNCLASSIFIED SECTION
Do not use if pouch
is torn or open
Breakthrough Products, Inc.
Denver, CO 80202
- PRINCIPAL DISPLAY PANEL - 1 Powder Packet
POUR DIRECTLY IN MOUTH
◀ SEE OPENING INSTRUCTIONS ON BACK PANEL ▶
UPSET STOMACH RELIEVER & ANTIDIARRHEAL
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 DEA Schedule 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)