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Imodium A-D by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Dosage form: tablet, film coated
Ingredients: Loperamide hydrochloride 2mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-317

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

Heart alert

Taking more than directed can cause serious heart problems or death

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; 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 2-5 years (34 to 47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use

Other information
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Warning and Directions

NDC 50580-317-03

Imodium®
A-D

Loperamide Hydrochloride Tablets, 2mg
Anti-Diarrheal

Anti-Diarrheal
Caplets

Controls the symptoms
of diarrhea

Actual Size

*Capsule-Shaped Tablets

24 Caplets*

IMODIUM   A-D
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:50580-317-011 BLISTER PACK in 1 CARTON
16 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:50580-317-034 BLISTER PACK in 1 CARTON
26 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:50580-317-046 BLISTER PACK in 1 CARTON
36 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:50580-317-058 BLISTER PACK in 1 CARTON
46 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523207/13/2015
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Medically reviewed on Mar 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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