First Aid Direct Peptum Tabs Tablet, Chewable
FDA Label NDC 42961-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corp for the product First Aid Direct Peptum Tabs (NDC 42961-109). 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 tablet), purpose, uses, warnings, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Bismuth Subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Purpose

Upset stomach reliever and anti-diarrheal

Uses

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms

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 asprin)
  • taking other salicylate products

Directions

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • children under 12: ask a doctor
  • drink plenty of fluids to help prevent dehydration which may accompany diarrhea

Other Information

  • each tablet contains:
  • sodium less than 1mg
  • salicylate 102 mg
    • very low sodium
    • avoid excessive heat (over 104°F or 40°C).
    • TAMPER EVIDENT: Do not use if individual compartments are torn or open.

Inactive Ingredients

calcium carbonate, D&C red 27 aluminum lake, flavor, mangesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Questions?

​1-800-327-2704

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