IMODIUM A-D- loperamide hydrochloride capsule, liquid filled

Imodium A-D by

Drug Labeling and Warnings

Imodium A-D 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 capsule)

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
• in children under 12 years of age

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.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• not for use in children under 12 years of age
• adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

• store at 20°-25°C (68°-77°F). Protect from light.
• avoid excessive heat above 40°C (104°F)
• do not use if blister unit is torn or broken

Inactive ingredients

butylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 50580-367-02

See New Warning

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

Anti-Diarrheal
Softgels

Controls the symptoms
of diarrhea

Suitable for adults and
children 12 years and over

24 Softgels*
Actual Size

*each liquid-filled capsule contains 2 mg loperamide HCl

INGREDIENTS AND APPEARANCE

IMODIUM A-D 
loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-367
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
butylated hydroxyanisole (UNII: REK4960K2U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
gelatin, unspecified (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
glyceryl monocaprylate (UNII: TM2TZD4G4A)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE (Light blue)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	IMO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-367-01	1 in 1 CARTON	07/11/2016
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-367-02	2 in 1 CARTON	07/11/2016
2		12 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
NDA	NDA021855	07/11/2016

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