berkley and jensen anti diarrheal description, usages, side effects, indications, overdosage, supplying and lots more!

berkley and jensen anti diarrheal

BJWC

  • 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
BJWC 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 printed foil under cap is broken or missing
  • see end panel for lot number and expiration date

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?

1-800-934-1204

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF IMODIUM® A-D

Loperamide Hydrochloride Tablets, 2 mg

Anti Diarrheal

Controls the Symptoms of Diarrhea, Including Travelers' Diarrhea

Actual Size

*Each caplet (capsule-shaped tablet) contains 2 mg loperamide hydrochloride

Principal Display Panel
Anti Diarrheal Carton Image 1 Anti Diarrheal Carton Image 2

berkley and jensen anti diarrheal

Loperamide Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68391-224
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
GREEN 10 mm L2 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 96 in 1 BOTTLE
2 NDC:68391-224-01 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075232 2003-04-19


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Be sure to consult your doctor before taking any medication!
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