IMODIUM A-D- loperamide hydrochloride tablet, film coated

Imodium by

Drug Labeling and Warnings

Imodium by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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
• a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Loperamide may interact with certain prescription drugs.

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 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 Warnings

NDC: 50580-317-06

Imodium®
A-D

Loperamide Hydrochloride Tablets, 2mg
Anti-Diarrheal

Anti-Diarrheal
Caplets

Controls the symptoms
of diarrhea

Actual Size

*Capsule-Shaped Tablets

12 Caplets*

INGREDIENTS AND APPEARANCE

IMODIUM   A-D
loperamide hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-317
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loperamide hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II)	Loperamide hydrochloride	2 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous lactose (UNII: 3SY5LH9PMK)
carnauba wax (UNII: R12CBM0EIZ)
hypromellose, unspecified (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	IMO;2;MG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-317-01	1 in 1 CARTON	07/13/2015
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-317-03	4 in 1 CARTON	07/13/2015
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50580-317-04	6 in 1 CARTON	07/13/2015	12/31/2018
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 50580-317-05	8 in 1 CARTON	07/13/2015
4		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 50580-317-06	2 in 1 CARTON	02/10/2020
5		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075232	07/13/2015

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)