Loperamide Hydrochloride Solution
FDA Label NDC 55910-155

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp Inc for the product Loperamide Hydrochloride (NDC 55910-155). 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 7.5 ml), purpose, use, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, 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

Heart alert:Taking more than directed can cause serious heart problems or death

Do not use if outer neck bandis broken or missing

PEEL OPEN TO READ COMPLETE DIRECTIONS AND WARNINGS BEFORE PURCHASE

*This product is not manufactured or distributed by the owners of Imodium ®A-D.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN INDIA

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984006960

L0001226 R0226 A1791

Code: TN/Drugs/TN00002222/2006

Active Ingredient (In Each 7.5 Ml)

Loperamide HCl, USP 1 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Otc - Do Not Use

Do not useif you have bloody or black stool

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

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.

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 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
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • shake well before using
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
    • adults and children 12 years and over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
    children 9 years to 11 years (60 lbs to 95 lbs)15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
    children 6 years to 8 years (48 lbs to 59 lbs)15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours
    children 2 years to 5 years (34 lbs to 47 lbs)ask a doctor
    children under 2 years (up to 33 lbs)do not use

Other Information

  • each 30 mL contains: sodium 7 mg
  • store at 20°C to 25°C (68°F to 77°F)
  • do not use if outer neck band is broken or missing.

Inactive Ingredients

anhydrous citric acid, D&C yellow no. 10, FD&C blue no. 1, flavadew coolmint, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, plain caramel powder, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions Or Comments?

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