Anti Diarrheal description, usages, side effects, indications, overdosage, supplying and lots more!

Anti Diarrheal

Kroger Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Kroger Co. Anti-Diarrheal Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Uses

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.

adults and children 12 years and over

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours

children 9-11 years (60-95 lbs)

1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours

children 6-8 years (48-59 lbs)

1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

children under 6 years (up to 47 lbs)

ask a doctor

Other information

  • •store at 20°-25°C (68°-77°F)
  • •do not use if blister unit is broken or torn {For use on Blister Cartons Only}
  • •do not use if printed foil under cap is broken or missing {For use on Bottle Cartons Only}
  • •see end panel for lot number and expiration date {For use on Bottle Cartons Only}

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of IMODIUM® A-D

See top panel

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

CONTROLS THE SYMPTOMS OF DIARRHEA

72 CAPLETS*

*each caplet (capsule-shaped tablet) contains 2 mg Loperamide Hydrochloride

actual size

Anti Diarrheal

Loperamide Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-998
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
ANHYDROUS LACTOSE
carnauba wax
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
GREEN 10 mm L2 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 1 in 1 BLISTER PACK
3 48 in 1 BOTTLE
4 72 in 1 BOTTLE
5 NDC:30142-998-23 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075232 2003-02-21


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Be sure to consult your doctor before taking any medication!
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