Stomach Liquid
FDA Label NDC 66715-5555

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc for the product Stomach (NDC 66715-5555). 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 30 ml), purpose, uses, reye's syndrome, allergy alert, 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

Drug Facts

Active Ingredient (In Each 30 Ml)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

  • diarrhea
  • travelers' diarrhea
  • upset stomach due to overindulgence in food and drink, including
    • heartburn
    • gas
    • indigestion
    • nausea
    • fullness
    • 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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning of the blood)

Otc - When Using

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

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. (1-800-222-1222)

Directions

  • mL = milliliter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • adults and children 12 years and over:
  • 30 mL (1 dose) every ½ to 1 hour as needed
  • do not exceed 8 doses (240 mL) 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

Other Information

  • each 30 mL contains: sodium 10 mg
  • each 30 mL contains: salicylate 243 mg
  • sugar free
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions Or Comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Principal Display Panel - 237 Ml Bottle Label

QUALITY
GUARANTEED

Compare to the Active
Ingredient in Pepto-Bismol®*

Stomach

Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal

Relieves
• Diarrhea • Upset Stomach
• Heartburn • Indigestion • Nausea

8 FL OZ
(237 mL)

Lil'
Drug Store®

* Please review the disclaimer below.