Loperamide Hydrochloride Solution
FDA Label NDC 81033-067

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Loperamide Hydrochloride (NDC 81033-067). 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 7.5 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 7.5 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

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ *this Product Is Not Manufactured Or Distributed By The Owners Of Imodium ®a-d.

→ Principal Display Panel

→ Package Label.principal Display Panel

Active Ingredient (In Each 7.5 Ml)

Loperamide HCl, USP 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
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

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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. (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

mL = milliliter

adults and children 12 years and over	30 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)
Loperamide HCl Oral Solution is a light green opaque, cool mint flavored solution supplied in the following:

NDC 81033-067-07: 7.5 mL unit-dose cup
NDC 81033-067-34: Carton containing 30 unit-dose cups of 7.5 mL each
NDC 81033-067-15: 15 mL unit-dose cup
NDC 81033-067-35: Carton containing 30 unit-dose cups of 15 mL each

Inactive Ingredients

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