IMODIUM A-D - loperamide hydrochloride liquid 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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Imodium®
A-D

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

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
• only use attached measuring cup to dose product

adults and children 12 years and over	30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours
children 9-11 years (60-95 lbs)	15 mL (3 tsp) after first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours
children 6-8 years (48-59 lbs)	15 mL (3 tsp) after first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Other information

• each 30 mL (6 tsp) 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
• see side panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, D&C yellow #10, FD&C blue #1, glycerin, flavor, microcrystalline cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

NDC 50580-134-44

For ages
6 years & up

Imodium®
A-D
Loperamide HCl

Anti-Diarrheal
Controls the symptoms
of diarrhea

mint flavor
1 mg loperamide
HCl per 7.5 mL

4 FL OZ (120 mL)

IMODIUM  A-D loperamide hydrochloride   liquid

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Loperamide Hydrochloride (Loperamide) Loperamide 1 mg  in 7.5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

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

Packaging # NDC Package Description Multilevel Packaging 1 50580-134-04 120 mL In 1 BOTTLE None 2 50580-134-44 120 mL In 1 BOTTLE None 3 50580-134-08 240 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019487	01/01/2005

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 09/2009McNeil Consumer Healthcare Div McNeil-PPC, Inc