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Imodium A-D by REMEDYREPACK INC.

Medically reviewed on February 21, 2017

Dosage form: tablet, film coated
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: REMEDYREPACK INC.
NDC Code: 61786-439

Imodium ®

A-D

Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 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.
adults and children 12 years and over2 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; ½ 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; ½ 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 between 20-25 °C (68-77 °F)
  • do not use if carton or blister unit is open or torn

Inactive ingredients

anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

DRUG: Imodium A-D A-D

GENERIC: Loperamide hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-439-02

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 11 mm

IMPRINT: IMO;2;MG

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Loperamide hydrochloride 2mg in 1

INACTIVE INGREDIENT(S):

  • anhydrous lactose
  • magnesium stearate
  • microcrystalline cellulose
  • carnauba wax
  • hypromellose, unspecified
  • polyethylene glycol, unspecified

IMODIUM A-D 
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-439(NDC:50580-317)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize11mm
FlavorImprint CodeIMO;2;MG
Contains    
Packaging
#Item CodePackage Description
1NDC:61786-439-0230 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523202/21/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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