Qc Quality Choice Pink Bismuth Stomach Relief
FDA Label NDC 63868-303

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Manufacturing Assn for the product Qc Quality Choice Pink Bismuth Stomach Relief (NDC 63868-303). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient(in each 15 ml tablespoon), purposes, uses, reye's syndrome:, allergy alert: contains salicylate. do not take if you are, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(in Each 15 Ml Tablespoon)

→ Purposes

→ Uses

→ Reye's Syndrome:

→ Allergy Alert: Contains Salicylate. Do Not Take If You Are

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 236 Ml Bottle Label

Other

Drug Facts

Active Ingredient(In Each 15 Ml Tablespoon)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

travelers’diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
upset stomach
nausea
gas
belching

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

Otc - Do Not Use

Do not use if you have

an ulcer
a bleeding problem
bloody or black stool

Otc - Ask Doctor

Ask a doctor before use if you have

fever
mucus in the stool

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Otc - When Using

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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 right away.

Directions

shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over:
1 dose (2 tbsp or 30 ml) every ½ 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 tbsp contains: sodium 6 mg
- low sodium
- sugar free
- salicylate 130 mg
- protect from freezing
- avoid excessive heat (more than 104°F or 40°C)
- TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken.

Inactive Ingredients

carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide ,potassium sorbate, purified water, red 22,red 28, salicylic acid, simethicone emulsion, sodium benzoate ,sucralose, xanthan gum