IMODIUM AD- loperamide hydrochloride tablet, coated

Imodium AD by

Drug Labeling and Warnings

Imodium AD by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, 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

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 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 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 pouch is open or torn
• see bottom 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

SPL UNCLASSIFIED SECTION

Repackaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc.
1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 2 caplet carton

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

Anti-Diarrheal

Controls the symptoms
of diarrhea

2 CAPLETS

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

IMODIUM AD 
loperamide hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9720
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
silicon dioxide (UNII: ETJ7Z6XBU4)
dibasic calcium phosphate dihydrate (UNII: O7TSZ97GEP)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
aluminum oxide (UNII: LMI26O6933)
FD&C blue no. 1 (UNII: H3R47K3TBD)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)

Product Characteristics
Color	GREEN (Light Green)	Score	no score
Shape	OVAL (Capsule shaped)	Size	15mm
Flavor		Imprint Code	IMODIUM;A;D;2MG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9720-1	1 in 1 CARTON	05/10/2010	09/19/2020
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019860	05/10/2010	09/19/2020

Labeler - Lil' Drug Store Products, Inc. (093103646)