Upset Stomach Relief To Go™

Upset Stomach Relief To Go™
SPL v4
SPL
SPL Set ID a019eedf-073d-43c6-ad30-dedb9dd51fbd
Route
ORAL
Published
Effective Date 2014-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (525 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose Silicon Dioxide Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-01

Description

Drug Facts

Purpose

Upset stomach reliever/antidiarrheal


Medication Information

Purpose

Upset stomach reliever/antidiarrheal

Description

Drug Facts

Uses

Relieves:

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any drug for:

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50570-1

Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Section 53414-9

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

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

Questions?

1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

Allergy Alert

Contains salicylate.

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.

Other Information

each dose contains salicylate 199mg

Inactive Ingredients

citric acid, flavor, glucose, silica, sucralose

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
Active Ingredient (per Powder)

Bismuth subsalicylate 525mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
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


Structured Label Content

Uses

Relieves:

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any drug for:

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50570-1 (50570-1)

Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Section 53414-9 (53414-9)

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

Purpose

Upset stomach reliever/antidiarrheal

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

Questions?

1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

Allergy Alert (Allergy alert)

Contains salicylate.

Reye's Syndrome (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.

Other Information (Other information)

each dose contains salicylate 199mg

Inactive Ingredients (Inactive ingredients)

citric acid, flavor, glucose, silica, sucralose

Stop Use and Ask A Doctor If (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
Active Ingredient (per Powder) (Active ingredient (per powder))

Bismuth subsalicylate 525mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Principal Display Panel 1 Powder Packet (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


Advanced Ingredient Data


Raw Label Data

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