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

Menu
Search

Leader Loperamide Hydrochloride

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 1/2 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 1/2 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 Hydrochloride Other information

  • •each 30 mL (6 tsp) contains: sodium 13 mg
  • •store between 20-25°C (68-77°F)
  • •do not use if printed plastic neckband is broken or missing
  • •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

Loperamide Hydrochloride Oral Suspension

Anti-Diarrheal

Controls the Symptoms of Diarrhea

Mint Flavor

1 mg Loperamide Hydrochloride per 7.5 mL

Leader Loperamide Hydrochloride

loperamide HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-584
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 (opaque, viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-584-26 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091292 2012-03-28


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.