046 - Stomach Relief

046 - Stomach Relief
SPL v2
SPL
SPL Set ID 459abf99-63e8-43d7-a13c-9e4682698415
Route
ORAL
Published
Effective Date 2024-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Aspartame Acacia Calcium Carbonate D&c Red No. 27 Aluminum Lake Dextrates Magnesium Stearate Maltodextrin Microcrystalline Cellulose Peppermint Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RH046 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-30

Description

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

Antidiarrheal/Antacid


Medication Information

Purpose

Antidiarrheal/Antacid

Description

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Use(s)
  • relieves
  • travelers’ diarrhea
  • diarrhea  
  • upset stomach due to overindulgence in food and drink including:  
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
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
Directions

Chew or dissolve in mouth

Adults and children 12 years and over:

  • 2 tablets (1 dose) every 1/2; hour or 4 tablets (2 doses) every

    hour as needed for diarrhea 
  • 2 tablets (1 dose) every 1/2; hour as needed for overindulgence (upset

    stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years of age: ask a doctor

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Do Not Use
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information

Phenylketonurics: contains phenylalanine 1.1mg per tablet

Calcium content per tablet: 73mg

  • store at room temperature 15°– 30°C (59°– 86°F)
  • do not use if cellophane unit is torn
Active Ingredient(s)

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum

lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor,

silicon dioxide

Principal Display Panel
Stomach Relief
When Using This Product

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

Ask A Doctor Before Use If
  • fever
  • mucus in the stool
Stop Use and Ask A Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

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

(1-800-222-1222) right away.

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

Use(s)
  • relieves
  • travelers’ diarrhea
  • diarrhea  
  • upset stomach due to overindulgence in food and drink including:  
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Purpose

Antidiarrheal/Antacid

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
Directions

Chew or dissolve in mouth

Adults and children 12 years and over:

  • 2 tablets (1 dose) every 1/2; hour or 4 tablets (2 doses) every

    hour as needed for diarrhea 
  • 2 tablets (1 dose) every 1/2; hour as needed for overindulgence (upset

    stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years of age: ask a doctor

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Do Not Use (Do not use)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information (Other information)

Phenylketonurics: contains phenylalanine 1.1mg per tablet

Calcium content per tablet: 73mg

  • store at room temperature 15°– 30°C (59°– 86°F)
  • do not use if cellophane unit is torn
Active Ingredient(s) (Active ingredient(s))

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Inactive Ingredients (Inactive ingredients)

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum

lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor,

silicon dioxide

Principal Display Panel
Stomach Relief
When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)
  • fever
  • mucus in the stool
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

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

(1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If (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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