gnp pink bismuth tablets

gnp pink bismuth tablets
SPL v2
SPL
SPL Set ID 9f5df648-298a-43e3-b250-8db6786fc93f
Route
oral
Published
Effective Date 2025-01-20
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 mannitol cellulose, microcrystalline polysorbate 80 sodium starch glycolate type a corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-08-08

Purpose

Upset stomach reliever and anti-diarrheal

Description

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


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:

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

Upset stomach reliever and anti-diarrheal

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
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
Other Information
  • very low sodium, each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg.
  • 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&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Description

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

Pdp

Good Neighbor Pharmacy

COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT

protective coating

Pink Bismuth

Soothing relief for

: upset stomach, indigestion, nausea, heartburn and diarrhea

40 caplets

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

(total salicylate 102 mg per caplet)

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

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:

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

Upset stomach reliever and anti-diarrheal

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
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
Other Information (Other information)
  • very low sodium, each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg.
  • 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&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Pdp (PDP)

Good Neighbor Pharmacy

COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT

protective coating

Pink Bismuth

Soothing relief for

: upset stomach, indigestion, nausea, heartburn and diarrhea

40 caplets

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

(total salicylate 102 mg per caplet)

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.


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