Loperamide Hydrochloride

Precision Dose Inc.

LOPERAMIDE HYDROCHLORIDE ORAL SUSPENSION

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient (in each 7.5 mL)
• Purpose
• Use
• Warnings
  • Allergy alert
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Other Information
• Inactive ingredients
• How Supplied
• PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

FULL PRESCRIBING INFORMATION

1 mg/7.5 mL
2 mg/15 mL

Mint Flavor

For Hospital Use Only

Drug Facts

Active Ingredient (in each 7.5 mL)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Use

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. (1-800-222-1222)

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• shake well before using
• use as directed per healthcare professional

Other Information

• each 30 mL (6 tsp) contains: sodium 13 mg
• store between 20-25°C (68-77°F)
• See individual label or shipper label for lot number and expiration date.

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

Gluten Free

How Supplied

NDC 68094-107-62
7.5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-108-62
15 mL per unit dose cup
Thirty (30) cups per shipper

Manufactured By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
South Beloit, IL 61080

LI911
Rev. 04/13

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

NDC 68094-108-59

PrecisionDose ™

LOPERAMIDE Hydrochloride
Oral Suspension
2 mg/15 mL

Delivers 15 mL Shake Well
Gluten free Contains 7 mg Sodium

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