heb stomach relief

heb stomach relief
SPL v3
SPL
SPL Set ID fac642cf-f2f7-4857-b54f-82f1dcb400ab
Route
oral
Published
Effective Date 2024-12-26
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (262 mg)
Inactive Ingredients
calcium carbonate d&c red no. 27 magnesium stearate mannitol starch, corn saccharin sodium

Identifiers & Packaging

Pill Appearance
Imprint: G122 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-10-21

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)


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 behaviour 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


Purpose

Upset stomach reliever and anti-diarrheal

Directions
  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused diarrhea
Other Information
  • each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn on open. 
Inactive Ingredients

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

Description

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

Principal Display Panel

Compare to Pepto-Bismol® Chewable active Ingredient*

NDC 37808-937-77

HEB

Stomach Relief

Bismuth Subsalicylate, 262 mg

Upset Stomach Reliever / Anti-diarrheal

Multi-Symptom Relief



Relief of:



  • Nausea
  • Heartburn
  • Indigestion
  • Upset stomach
  • Diarrhea




30 CHEWABLE TABLETS







Use(s)

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
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 Tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)



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 behaviour 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


Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Directions (DIRECTIONS)
  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused diarrhea
Other Information (OTHER INFORMATION)
  • each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn on open. 
Inactive Ingredients (INACTIVE INGREDIENTS)

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to Pepto-Bismol® Chewable active Ingredient*

NDC 37808-937-77

HEB

Stomach Relief

Bismuth Subsalicylate, 262 mg

Upset Stomach Reliever / Anti-diarrheal

Multi-Symptom Relief



Relief of:



  • Nausea
  • Heartburn
  • Indigestion
  • Upset stomach
  • Diarrhea




30 CHEWABLE TABLETS







Use(s) (USE(S))

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
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 Tablet) (ACTIVE INGREDIENT(in each tablet))

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)



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

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