Loperamide HCl description, usages, side effects, indications, overdosage, supplying and lots more!

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Loperamide HCl

McKesson

Loperamide HCl Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Loperamide HCI 2 mg

Anti-diarrheal

controls symptoms of diarrhea, including Travelers'Diarrhea

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.

  • 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
  • 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

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

Product Labeling





















Loperamide HCl

Loperamide HCl

LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62011-0158
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 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 Size Imprint Code Shape
blue 19 mm p13 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:62011-0158-1 2 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021855 2012-06-25


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Be sure to consult your doctor before taking any medication!
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