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

IMODIUM A-D (loperamide hydrochloride) tablet
[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 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; 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

  • each caplet contains: calcium 10 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-295-06

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

Anti-Diarrheal

Controls the symptoms
of diarrhea

6 Caplets

Principal Display Panel
IMODIUM   A-D
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-295
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide hydrochloride (Loperamide) Loperamide hydrochloride2 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
calcium phosphate, dibasic, dihydrate 
D&C Yellow no. 10 
FD&C Blue no. 1 
magnesium stearate 
aluminum oxide 
cellulose, microcrystalline 
Product Characteristics
ColorGREEN (Light green) Score2 pieces
ShapeOVALSize11mm
FlavorImprint Code IMODIUM;A;D;2mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-295-061 in 1 CARTON
16 in 1 BLISTER PACK
2NDC:50580-295-122 in 1 CARTON
26 in 1 BLISTER PACK
3NDC:50580-295-244 in 1 CARTON
36 in 1 BLISTER PACK
4NDC:50580-295-305 in 1 CARTON
46 in 1 BLISTER PACK
5NDC:50580-295-4910 in 1 CARTON
56 in 1 BLISTER PACK
6NDC:50580-295-5036 in 1 CARTON
62 in 1 POUCH
7NDC:50580-295-552 in 1 POUCH
8NDC:50580-295-7212 in 1 CARTON
86 in 1 BLISTER PACK
9NDC:50580-295-848 in 1 CARTON
96 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01986012/01/1989
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 4/2012
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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