LOPERAMIDE HYDROCHLORIDE  - loperamide hydrochloride capsule, liquid filled 
Banner Pharmacaps Inc.

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Drug Facts

Active ingredient(in each capsule)

Loperamide HCI 2 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

Ask a doctor before use if you have

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 doctor if

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.

Directions

Other information

Inactive ingredients


butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

                                                                                          Manufactured by:
                                                                                     Banner Pharmacaps Inc.
                                                                                       4125 Premier Drive
                                                                                      High Point, NC 27265

Principal Display Panel-Shipping Label

NDC 10888-7098-1

Loperamide HCl, 2 mg

(Liquid Filled Capsules)

20,000 Softgels

2 mg
IMPORTANT

This bulk shipment, is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate.

CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY.

BANNER PHARMACAPS Inc BULK LABEL


LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride   capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 10888-7098
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE  
FD&C BLUE NO. 1  
GELATIN  
GLYCERIN  
GLYCERYL CAPRYLATE  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
WATER  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 10888-7098-1 1 BAG In 1 BOX contains a BAG
1 20000 CAPSULE In 1 BAG This package is contained within the BOX (10888-7098-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021855 02/06/2006

Labeler - Banner Pharmacaps Inc. (002193829)
Revised: 09/2010 Banner Pharmacaps Inc.