Your browser does not support JavaScript! IMODIUM (LOPERAMIDE HYDROCHLORIDE) TABLET, CHEWABLE [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]
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RxNorm Names

IMODIUM (loperamide hydrochloride) tablet, chewable
[McNeil Consumer Healthcare Div. McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredient (in each tablet)

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
  • take only on an empty stomach (1 hour before or 2 hours after a meal)
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children
12 years and over
chew 2 tablets after the first loose stool;
chew 1 tablet after each subsequent loose stool;
but no more than 4 tablets in 24 hours
children 9-11 years
(60-95 lbs)
chew 1 tablet after the first loose stool;
chew ½ tablet after each subsequent loose stool;
but no more than 3 tablets in 24 hours
children 6-8 years
(48-59 lbs)
chew 1 tablet after the first loose stool;
chew ½ tablet after each subsequent loose stool;
but no more than 2 tablets in 24 hours
children under 6 years
(up to 47 lbs)
ask a doctor

Other information

  • contains milk
  • store between 20-25° C (68-77° F)
  • do not use if carton is open or if printed foil seal under bottle cap is open or torn
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, basic polymethacrylate, cellulose acetate, confectioner's sugar, crospovidone, D&C yellow #10 aluminum lake, dextrose excipient, FD&C blue #1 aluminum lake, flavors, magnesium stearate, microcrystalline cellulose, milk powder, sucralose

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-397-20

Imodium®
A-D Loperamide HCl, 2 mg/Anti-Diarrheal

EZ CHEWS®

Anti-Diarrheal

Controls the symptoms
of diarrhea

20 Chewable
Cool Mint Flavored Tablets

Principal Display Panel
IMODIUM   A-D
loperamide hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-397
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide hydrochloride (Loperamide) Loperamide hydrochloride2 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
cellulose acetate 
crospovidone 
D&C yellow no. 10 
aluminum oxide 
FD&C blue no. 1 
magnesium stearate 
cellulose, microcrystalline 
sucralose 
Product Characteristics
ColorGREEN (Light green) Score2 pieces
ShapeROUNDSize12mm
FlavorMINTImprint Code IMO;2;MG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-397-201 in 1 CARTON
120 in 1 BOTTLE, PLASTIC
2NDC:50580-397-251 in 1 CARTON
225 in 1 BOTTLE, PLASTIC
3NDC:50580-397-401 in 1 CARTON
340 in 1 BOTTLE, PLASTIC
4NDC:50580-397-411 in 1 CARTON
450 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02044802/01/2007
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 11/2010
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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