IMODIUM A-D- loperamide hydrochloride solution

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 7.5 mL)

Loperamide HCl 1 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

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.
• shake well before using
• use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
• mL = milliliter

• adults and children 12 years and over: 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
• children 9-11 years (60-95 lbs): 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
• children 6-8 years (48-59 lbs): 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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

• each 30 mL contains: sodium 16 mg
• store between 20-25°C (68-77°F)
• do not use if printed inner or outer neckband is broken or missing.

Inactive ingredients

anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 50580-134-04

See New Warning
and Directions

Imodium®
A-D
Loperamide HCl, Anti-Diarrheal
1 mg per 7.5 mL

Anti-Diarrheal
Oral Solution

Controls the symptoms
of diarrhea

4 fl oz
(120 mL)

Mint Flavor

INGREDIENTS AND APPEARANCE

IMODIUM   A-D
loperamide hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-134
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II)	Loperamide Hydrochloride	1 mg  in 7.5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
caramel (UNII: T9D99G2B1R)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C blue no. 1 (UNII: H3R47K3TBD)
glycerin (UNII: PDC6A3C0OX)
microcrystalline cellulose (UNII: OP1R32D61U)
propylene glycol (UNII: 6DC9Q167V3)
sodium benzoate (UNII: OJ245FE5EU)
sucralose (UNII: 96K6UQ3ZD4)
titanium dioxide (UNII: 15FIX9V2JP)
water (UNII: 059QF0KO0R)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	GREEN (opaque)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-134-04	120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/01/2004
2	NDC: 50580-134-44	120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/01/2004
3	NDC: 50580-134-08	240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019487	07/01/2004

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