Medique Diamode Tablet
FDA Label NDC 71205-316

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Medique Diamode (NDC 71205-316). 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 caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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 Caplet)

Loperamide HCl USP, 2mg

Purpose

Anti-diarrheal

Uses

Controls symptoms of diarrhea, including Travelers' Diarrhea.

Warnings

Allery alert:

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl.

Heart alert:

Taking more than directed can cause serious heart problems or death.

Do Not Use

  • if you have bloody or black stool

Ask A Doctor Before Use If You Have

  • a fever
  • mucus in the stool
  • a history of liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking antibiotics

When Using This Product

  • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use And Ask A Doctor If

  • symptoms get worse
  • diarrhea lasts more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

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

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

    • Adults and children (12 years and over): Take 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours.

    Children under 12 years: Do not give to children under 12 years of age.

Other Information

  • store between 68° - 77°F (20° - 25°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packet
  • see back of packet for lot number and expiration date

Inactive Ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10, FD&C Blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions Or Comments?

1-800-634-7680

Medique Diamode Label

Diamode

Controls the Symptoms of Diarrhea

Pull to Open

See New Warnings Information

Antidiarrheal • Loperamide HCl 2 mg

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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