Upset Stomach Relief To Go
FDA Label NDC 51596-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Breakthrough Products Inc. for the product Upset Stomach Relief To Go (NDC 51596-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (per powder), purpose, uses, reye's syndrome, allergy alert, otc - do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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

    • 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

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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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

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Principal Display Panel (1 Powder Packet)

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