Advil PM (diphenhydramine citrate and ibuprofen)

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

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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 TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0164
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine citrate (diphenhydramine ) diphenhydramine citrate38 mg
ibuprofen (ibuprofen) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBLUE (blue) Score no score
ShapeCAPSULE (slightly glossy smooth blue film coated) Size15mm
FlavorImprint Code Advil;PM
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0164-044 CAPSULE In 1 POUCHNone
20573-0164-201 BOTTLE In 1 CARTONcontains a BOTTLE
220 CAPSULE In 1 BOTTLEThis package is contained within the CARTON (0573-0164-20)
30573-0164-301 BOTTLE In 1 CARTONcontains a BOTTLE
340 CAPSULE In 1 BOTTLEThis package is contained within the CARTON (0573-0164-30)
40573-0164-401 BOTTLE In 1 CARTONcontains a BOTTLE
480 CAPSULE In 1 BOTTLEThis package is contained within the CARTON (0573-0164-40)
50573-0164-431 BOTTLE In 1 CARTONcontains a BOTTLE
5120 CAPSULE In 1 BOTTLEThis package is contained within the CARTON (0573-0164-43)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139412/21/2005

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