Meijer Stomach Relief Suspension
FDA Label NDC 41250-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer Stomach Relief (NDC 41250-211). 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 active ingredient (in each 15 ml dose), purposes, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 15 Ml Dose)

→ Purposes

→ Uses

→ Warnings

→ Do Not Use If You Have

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each 15 Ml Dose)

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

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

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 or 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

Do Not Use If You Have

▪an ulcer
▪a bleeding problem
▪bloody or black stool

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 the blood)
▪diabetes
▪gout
▪arthritis

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 or last more than 2 days
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

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

Directions

shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over: 15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
do not exceed 8 doses (120 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 15 mL contains: sodium 10 mg
salicylate 230 mg
low sodium
sugar free
store at room temperature
protect from freezing
avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum