Anti Diarrheal
FDA Label NDC 21695-978

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Anti Diarrheal (NDC 21695-978). 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 5 ml), purpose, uses, warnings, 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

Active Ingredient (In Each 5 Ml)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Uses

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

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

Do Not Use

if you have bloody or black stool

Ask A Doctor Before Use If You Have

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

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.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • only use attached measuring cup to dose product
    • adults and children 12 years and over4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours
    children 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours
    children 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls in 24 hours
    children under 6 years (up to 47 lbs)ask a doctor

Other Information

  • do not use if carton is opened or if printed plastic neckband is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date

Inactive Ingredients

alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions Or Comments?

1-800-719-9260

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