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

• if you have bloody or black stool
• in children under 12 years of age (see Other information )

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 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.
• side effects occur. You may want to report side effects to FDA at 1800-FDA-1088.

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

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• not for use in children under 12 years of age
• adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

• do not use if carton or blister unit is open or torn
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F).
• see side panel for lot number and expiration date
• use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age

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

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: 09/2010Banner Pharmacaps Inc.