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Cardinal Health

Cardinal Health Loperamide Hydrochloride Oral suspension Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
  • •find right dose on chart. If possible, use weight to dose; otherwise use age.
  • •shake well before using
  • •only use attached measuring cup to dose product

adults and children 12 years and over

30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

children 9-11 years (60-95 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

children 6-8 years (48-59 lbs)

15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours

children under 6 years (up to 47 lbs)

ask a doctor

leader loperamide Other information

  • •each 30 mL (6 tsp) contains: sodium 15 mg
  • •store between 20-25°C (68-77°F)
  • •see side panel 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

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Imodium® A-D active ingredient

For Ages 6 Years and Up

Loperamide Hydrochloride Oral Suspension

Anti-Diarrheal

Mint Flavor

Controls the Symptoms of Diarrhea

4 FL OZ (120 mL)

1 mg Loperamide Hydrochloride per 7.5 mL

leader loperamide

Loperamide Hydrochloride SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49781-089
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 1 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GLYCERIN
cellulose, microcrystalline
propylene glycol
water
SODIUM BENZOATE
Sucralose
titanium dioxide
XANTHAN GUM

Product Characteristics

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49781-089-04 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091292 2014-05-30


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Be sure to consult your doctor before taking any medication!
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