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

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Loperamide Hydrochloride

Hi-Tech Pharmacal Co., Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

Antidiarrheal

Loperamide Hydrochloride Uses

  • controls the symptoms of diarrhea, including Traveler's Diarrhea

Warnings

Alergy 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

  • high fever (greater than 101°F)
  • mucus present in your stool
  • a history of liver disease

Ask doctor or pharmacist before use if you are taking antibiotics

Stop use and ask a doctor if diarrhea lasts for more than 2 days

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

  • use enclosed dosage cup to accurately measure dosage as noted below
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and older 4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a day
children 9-11 years (60-95 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a day
children 6-8 years (48-59 lbs) 2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a day
children under 6 years (up to 47 lbs) ask a doctor (not intended for use in children under 6 years old)

Loperamide Hydrochloride Other information

  • avoid excess heat
  • store at room temperature, 15° - 30°C (59° - 86°F)

Inactive ingredients

alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

Questions or comments?

Call 1-800-262-9010

Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST

Serious side effects associated with use of this product may be reported to this number.



Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701


Rev. 618:05 4/12

Principal Display Panel

Loperamide Hydrochloride

NDC 50383-618-04

Loperamide Hydrochloride Oral Solution

1 mg/5 mL

Anti-Diarrheal

Controls the Symptoms of Diarrhea, including Travelers' Diarrhea

Each teaspoonful (5 mL) contains:

Loperamide Hydrochloride 1 mg

Contains Alcohol 0.5%

Convenient dosage cup enclosed.

4 fl oz (118 mL)

CHERRY MINT FLAVOR

 

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

Loperamide Hydrochloride

Loperamide Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50383-618
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
ALCOHOL
ANHYDROUS CITRIC ACID
BENZOIC ACID
CHERRY
GLYCERIN
MINT
propylene glycol
SODIUM BENZOATE
sorbitol
SUCROSE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:50383-618-05 5 in 1 CUP, UNIT-DOSE
3 NDC:50383-618-10 10 in 1 CUP, UNIT-DOSE
4 10 in 1 TRAY
5 NDC:50383-618-11 4 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074352 1995-11-17


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Be sure to consult your doctor before taking any medication!
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