ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated

ADVIL PM by

Drug Labeling and Warnings

ADVIL PM by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Wyeth Pharmaceuticals Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep

WARNINGS

Allergy alert:

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

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

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

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• unless you have time for a full night's sleep
• in children under 12 years of age
• right before or after heart surgery
• with any other product containing diphenhydramine, even one used on skin
• if you have sleeplessness without pain

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic
• you have a breathing problem such as emphysema or chronic bronchitis
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor's care for any continuing medical illness
• taking any other antihistamines
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

When using this product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear

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 reach of children.

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

DIRECTIONS

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime
• do not take more than 2 caplets in 24 hours

OTHER INFORMATION

• read all warnings and directions before use. Keep carton.
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)

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

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

20
Caplets

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.

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

20
Coated Caplets*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Label

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

50
Caplets

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.

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

25%
MORE
FREE

Advil®PM

10 Free
Caplets

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

50
Coated Caplets*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

2 Caplets

PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

Coated Caplets*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 120 Caplet Bottle Label

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Use℠

CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

120
Coated Caplets*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 8 Caplet Vial Label

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

8
Caplets

PRINCIPAL DISPLAY PANEL - 8 Caplet Vial Package

Home &
Travel

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

Do not use if blister is open or the words
"ADVIL SAFETY SEALED" under blister
are missing or torn.

8
Coated Caplets*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 8 Caplet Vial - Loose

Advil®PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

8
Coated Caplets*
*Capsule-Shaped Tablets

INGREDIENTS AND APPEARANCE

ADVIL PM 
diphenhydramine citrate and ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0164
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE CITRATE	38 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE (UNII: 776XM7047L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (blue)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	Advil;PM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0164-33	1 in 1 CARTON	12/21/2005
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0573-0164-04	4 in 1 POUCH; Type 0: Not a Combination Product	12/21/2005
3	NDC: 0573-0164-20	1 in 1 CARTON	12/21/2005
3		20 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0573-0164-30	1 in 1 CARTON	12/21/2005
4		40 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0573-0164-40	1 in 1 CARTON	12/21/2005
5		80 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0573-0164-43	1 in 1 CARTON	12/21/2005
6		120 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0573-0164-45	1 in 1 CARTON	12/21/2005
7		180 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0573-0164-32	1 in 1 CARTON	12/21/2005
8		50 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 0573-0164-41	1 in 1 CARTON	12/21/2005
9		100 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 0573-0164-91	3000 in 1 BOX	12/21/2005
10		2 in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 0573-0164-05	2 in 1 CARTON	12/21/2005
11		2 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 0573-0164-55	50 in 1 TRAY	12/21/2005
12		2 in 1 POUCH; Type 0: Not a Combination Product
13	NDC: 0573-0164-21	1 in 1 CARTON	12/21/2005
13		30 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 0573-0164-44	1 in 1 CARTON	12/21/2005
14		140 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 0573-0164-14	2 in 1 CARTON	12/21/2005
15		2 in 1 POUCH; Type 0: Not a Combination Product
16	NDC: 0573-0164-12	6 in 1 CARTON	12/21/2005
16		2 in 1 POUCH; Type 0: Not a Combination Product
17	NDC: 0573-0164-49	1 in 1 CARTON	12/21/2005
17		200 in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC: 0573-0164-46	1 in 1 CARTON	12/21/2005
18		180 in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC: 0573-0164-65	120 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2016
20	NDC: 0573-0164-08	1 in 1 PACKAGE	03/17/2017
20		8 in 1 VIAL; Type 0: Not a Combination Product
21	NDC: 0573-0164-09	8 in 1 VIAL; Type 0: Not a Combination Product	03/17/2017

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

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth Pharmaceuticals Company		829390975	ANALYSIS(0573-0164) , LABEL(0573-0164) , MANUFACTURE(0573-0164) , PACK(0573-0164)