Medique Diotame Tablet, Chewable
FDA Label NDC 47682-210

17 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medique Diotame (NDC 47682-210). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, 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

Otc - Active Ingredient

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Otc - Purpose

Purpose

antidiarrheal/antacid

Indications & Usage

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach reliever due to overindulgence in food and drink, including: • 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 salicylate products

Otc - Do Not Use

Do not use if you have

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

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 if you are taking any drug for

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

Otc - When Using

When using this product a temporary and harmless darkening of the tongue and/or stool may occur.

Otc - Stop Use

Stop use and ask a doctor if

  • symptoms get worse or lasts 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 accidental overdose, contact a physician or poison control center immediately (1-800-222-1222).

Dosage & Administration

Directions

  • chew or dissolve in mouth
  • do not swallow tablets whole
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea

    • Adults and children: (12 years and over)

    • chew 2 tablets every 1/2 to 1 hour as needed
    • do not exceed 16 tablets in 24 hours
    • use until diarrhea stops but not more than 2 days

      • ​Children under 12 years:

      ask a doctor

Other Safety Information

Other information

  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • calcium content per tablet: 73 mg
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredient

Inactive ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Otc - Questions

Questions or comments? 1-800-634-7680

Medique Diotame Label

Medique®

Diotame

Bismuth Subsalicylate

Chewable Tablets

Upset Stomach/Diarrhea • Bismuth Subsalicylate 262 mg

Tamper Evident Unit Dose Packets

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