Cvs Stomach Relief

Cvs Stomach Relief
SPL v2
SPL
SPL Set ID 53cf4590-a625-42f7-bd03-8401d08b6447
Route
ORAL
Published
Effective Date 2017-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate Silicon Dioxide D&c Red No. 27 Magnesium Stearate Polysorbate 80 Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-08

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 262 mg

Pdp

CVS Health

Stomach Relief

Bismuth Subsalicylate 262 mg

Upset stomach reliever / Antidiarrheal

Soothing relief for 5 symptoms:

Heartburn

Nausea

Indigestion

Diarrhea

Upset Stomach

Package contains One bottle

24 Caplets

Uses

relieves:

  • indigestion
  • nausea
  • heartburn
  • diarrhea
  • upset stomach associated with these symptoms
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
  • Swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 caplets) in 24 hours
  • use untill diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
Other Information
  • each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg.
  • very low sodium
  • TAMPER EVIDENT: Do not use if printed seal under cap is torn or missing.
  • store at room temperature, in a dry place
Inactive Ingredients

calcium carbonate, colloidal silicon dioxide, D and C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

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 A Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Active Ingredient (in Each Caplet)

Bismuth subsalicylate 262 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
If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. Keep Out of Reach of Children.

In case of overdose, get medical help or contact a poison control center immediately.


Structured Label Content

Pdp (PDP)

CVS Health

Stomach Relief

Bismuth Subsalicylate 262 mg

Upset stomach reliever / Antidiarrheal

Soothing relief for 5 symptoms:

Heartburn

Nausea

Indigestion

Diarrhea

Upset Stomach

Package contains One bottle

24 Caplets

Uses

relieves:

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

Upset stomach reliever and anti-diarrheal

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
  • Swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 caplets) in 24 hours
  • use untill diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
Other Information (Other information)
  • each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg.
  • very low sodium
  • TAMPER EVIDENT: Do not use if printed seal under cap is torn or missing.
  • store at room temperature, in a dry place
Inactive Ingredients (Inactive ingredients)

calcium carbonate, colloidal silicon dioxide, D and C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

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 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
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth subsalicylate 262 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 Taking Any Drug For (Ask a doctor or pharmacist before use if you are taking any drug for)
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. Keep Out of Reach of Children. (If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.)

In case of overdose, get medical help or contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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