FDA Label for Loperamide Hydrochloride

View Indications, Usage & Precautions

Loperamide Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Precision Dose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Mint Flavor

1 mg/7.5 mL 2 mg/15 mL

For Hospital Use Only

Drug Facts

Gluten Free

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

LI1251
Rev. 12/19

Active Ingredient (In Each 7.5 Ml)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Read complete directions and warnings before using.

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Otc - When Using

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.

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

Use as directed per healthcare professional.
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 9-11 years (60-95 lbs)	15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs)	15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours
children 2-5 years (34 to 47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

Other Information

each 30 mL contains: sodium 15 mg
store between 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

How Supplied

NDC 68094-029-62
7.5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-129-62
15 mL per unit dose cup
Thirty (30) cups per shipper

Otc - Questions

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

Principal Display Panel - 1 Mg/7.5 Ml Cup Lid Label

NDC 68094-029-59

PrecisionDose™

LOPERAMIDE Hydrochloride
Oral SOLUTION
1 mg/7.5 mL

Shake Well Delivers 7.5 mL Gluten Free
Contains 3.75 mg Sodium Hospital Use Only

Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1252 R0

PRINCIPAL DISPLAY PANEL - 1 mg/7.5 mL Cup Lid Label - loperamide 01

Principal Display Panel - 2 Mg/15 Ml Cup Lid Label

NDC 68094-129-59