Stomach Relief
FDA Label NDC 68210-0469

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Stomach Relief (NDC 68210-0469). 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, otc - purpose, uses, reye's syndrome, allergy alert, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

aerosil, beeswax, FD&C Red#33. FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl
cellulose, sorbitol solution, titanium dioxide

Otc - Purpose

Active ingredient                                                                                Purpose

(in each softgel)

Bismuth subsalicylate 262 mg...............Upset stomach reliever and anti-diarrheal

Uses

relieves

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

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

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

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.

Directions

  • swallow with water, do not chew
  • adults and children 12 years and over:
  •  2 softgels (1 dose) every 1/2 hour or 4 softgels (2
    doses) every hour as needed for diarrhea
  • 2 softgels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  •  do not exceed 8 doses (16 softgels) 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 softgel contains:
  •  salicylate 99 mg n very low sodium
  • store between 15-30°C (59-86°F)

Questions Or Comments?

1-888-333-9792

Principal Display Panel

VALUMEDS ™ 

Stomach Relief

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOM Digestive Relief

heartburn
indigestion
nausea
upset stomach
diarrhea
30 Softgels

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