loperamide hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

loperamide hydrochloride

Preferred Pharmaceuticals, Inc.

Major Pharmaceuticals 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

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

Loperamide Hydrochloride Oral Suspension

Anti-Diarrheal Liquid

Controls the Symptoms of Diarrhea

Mint Flavor

1 mg Loperamide Hydrochloride per 7.5 mL

COMPARE TO active ingredient in IMODIUM® A-D

loperamide hydrochloride

loperamide hydrochloride

loperamide HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9704(NDC:0904-6256)
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:68788-9704-1 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091292 2013-03-08


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.