Loperamide Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Mint Flavor

1 mg/7.5 mL 2 mg/15 mL

For Hospital Use Only

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 7.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers' Diarrhea

Read complete directions and warnings before using.

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

Heart alert

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious heart problems or death

OTC - DO NOT USE SECTION

Do not use if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever
• mucus in the stool
• a history of liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking antibiotics

OTC - WHEN USING SECTION

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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 SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Gluten Free

How Supplied

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed By
Perrigo Company
Allegan, MI 49010

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

OTC - QUESTIONS SECTION

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

SPL UNCLASSIFIED SECTION

LI1251 Rev. 04/22

PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68094-129-59

PrecisionDose™

LOPERAMIDE Hydrochloride
Oral SOLUTION
2 mg/15 mL

Shake Well Delivers 15 mL Gluten Free
Contains 7.5 mg Sodium Hospital Use Only

Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1253 R1

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

• Loperamide Hydrochloride
• Loperamide
• anhydrous citric acid
• carboxymethylcellulose sodium, unspecified
• D&C Yellow No. 10
• FD&C Blue No. 1
• Glycerin
• Microcrystalline cellulose
• propylene glycol
• water
• sodium benzoate
• sucralose
• titanium dioxide
• xanthan gum
• dimethicone
• silicon dioxide

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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Product history page 1 of 2 · 43 observed states.

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