gnp stomach relief original strength-527 

gnp stomach relief original strength-527 
SPL v2
SPL
SPL Set ID ead13b6b-de37-49f9-b18e-68096651d47e
Route
oral
Published
Effective Date 2024-12-20
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (525 mg)
Inactive Ingredients
benzoic acid d&c red no. 22 d&c red no. 28 potassium hydroxide water saccharin sodium salicylic acid hydroxyethyl cellulose (1500 mpa.s at 1%) dimethicone xanthan gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug active Since 2022-06-30

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 525 mg


Medication Information

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




Uses

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Purpose

Upset stomach reliever and anti-diarrheal

Directions
  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
  • each 30 mL or 2 TBSP contains:
  • potassium 25 mg
  • salicylate 260 mg
  • sodium 8 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided
Inactive Ingredients

benzoic acid, D&C red  22, D&C red  28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Description

Bismuth subsalicylate 525 mg

Principal Display Panel

GOOD NEIGHBOR PHARMACY®

NDC 46122-703-26

PROTECTIVE COATING ACTION

Stomach Relief

Original Strength

Anti-diarrheal / Upset Stomach Reliever

Bismuth subsalicylate (525mg/30mL)

soothing relief for: indigestion, nausea, heartburn, upset stomach & diarrhea

4 FL. OZ. (118 mL)



Do Not Use If You Have
  •    bloody or black stool   
  •    an ulcer
  •    a bleeding problem
When Using This Product

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient(in Each 30 Ml)

Bismuth subsalicylate 525 mg



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 of the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Warnings (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




Uses (USES)

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Directions (DIRECTIONS)
  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information (OTHER INFORMATION)
  • each 30 mL or 2 TBSP contains:
  • potassium 25 mg
  • salicylate 260 mg
  • sodium 8 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided
Inactive Ingredients (INACTIVE INGREDIENTS)

benzoic acid, D&C red  22, D&C red  28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

GOOD NEIGHBOR PHARMACY®

NDC 46122-703-26

PROTECTIVE COATING ACTION

Stomach Relief

Original Strength

Anti-diarrheal / Upset Stomach Reliever

Bismuth subsalicylate (525mg/30mL)

soothing relief for: indigestion, nausea, heartburn, upset stomach & diarrhea

4 FL. OZ. (118 mL)



Do Not Use If You Have (DO NOT USE IF YOU HAVE)
  •    bloody or black stool   
  •    an ulcer
  •    a bleeding problem
When Using This Product (WHEN USING THIS PRODUCT)

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
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 immediately.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

Active Ingredient(in Each 30 Ml) (ACTIVE INGREDIENT(in each 30 mL))

Bismuth subsalicylate 525 mg



Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

taking any drug for 



  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)