ADVIL PM - diphenhydramine citrate and ibuprofen capsule, coated 
Wyeth Consumer Healthcare

----------

Advil PM (diphenhydramine citrate and ibuprofen)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSES

Nighttime sleep-aid

Pain reliever

USES

WARNINGS

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg

Pain Reliever (NSAID) / Nighttime Sleep-Aid

40 Coated Caplets*

*Capsule-Shaped Tablets

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Wyeth

For most recent product information, visit www.Advil.com.

Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

Appearance of the blue Advil PM caplet is a trademark of Wyeth Consumer Healthcare

U.S. Patent Pending

Advil PM Caplets Packaging

ADVIL PM 
diphenhydramine citrate, ibuprofen   capsule, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0164
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diphenhydramine citrate (diphenhydramine ) diphenhydramine citrate 38 mg
ibuprofen (ibuprofen) ibuprofen 200 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color BLUE (blue) Score no score
Shape CAPSULE (slightly glossy smooth blue film coated) Size 15mm
Flavor Imprint Code Advil;PM
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0164-04 4 CAPSULE In 1 POUCH None
2 0573-0164-20 1 BOTTLE In 1 CARTON contains a BOTTLE
2 20 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0164-20)
3 0573-0164-30 1 BOTTLE In 1 CARTON contains a BOTTLE
3 40 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0164-30)
4 0573-0164-40 1 BOTTLE In 1 CARTON contains a BOTTLE
4 80 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0164-40)
5 0573-0164-43 1 BOTTLE In 1 CARTON contains a BOTTLE
5 120 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0164-43)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021394 12/21/2005

Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009 Wyeth Consumer Healthcare