Family Care Stomach Relief
FDA Label NDC 65923-626

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Stomach Relief (NDC 65923-626). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 30 mL dose cup)                                                       Purpose

Bismuth subsalicylate 525 mg..........................Upset stomach reliever and antidiarrheal

Otc - Purpose

Uses

relieves

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

Warnings

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 salicytate 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

    • Ask a doctor 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

  • diarrhea lasts more than 2 days
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs

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.

Indications & Usage

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 1/2 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

Storage And Handling

Other information

  • each 30 mL dose cup contains: sodium 10 mg
  • salicylate 202 mg
  • magnesium 25 mg
  • protect from freezing
  • avoid excessive heat (over 104° or 40°C)
  • low sodium

Inactive Ingredient

Inactive ingredients

FD&C Red No. 3, FD&C Red No. 40, hypromelloses, L-menthol, magnesium aluminum silicate, mint essence, polysorbate 80, propylene glycol, propylparaben, purified water, salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucrose, xanthan gum

Dosage & Administration

Distributed by:

United Exchange Corp.

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (626)

Image Description (626)

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