Private Label Distributor Tablet
FDA Label NDC 47682-021

Full FDA labeling including 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 Private Label Distributor (NDC 47682-021). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl

Active Ingredient (In Each Caplet)

Loperamide Hydrochloride 2mg

Purpose

Antidiarrheal

Uses

Controls the symptoms of diarrhea, including Travelers diarrhea.

Do Not Use

  • if you have bloody or black stool

Ask A Doctor Before Use If You Have

  • a fever
  • mucus in 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 you are pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or Poison Control Center right away.

Directions

  • do not use more than directed
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

    • Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 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 at room temperature 59° - 86°F (15° - 30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packet

Inactive Ingredients

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

Principal Display Panel - 200R Medique Diamode Label

Medique ®

Diamode

Controls the Symptoms of Diarrhea

Pull to Open

Antidiarrheal • Loperamide HCl 2 mg

50 Caplets

(50 x 1)

Tamper Evident Unit Dose Packets

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