ADVIL PM- diphenhydramine hcl, ibuprofen capsule, liquid filled

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPSULE)

Diphenhydramine hydrochloride 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt)

*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 capsules at bedtime
• do not take more than 2 capsules in 24 hours

OTHER INFORMATION

• each capsule contains: potassium 20 mg
• 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)
• protect from light

INACTIVE INGREDIENTS

D&C red no. 33, FD&C blue no. 1, medium-chain triglycerides, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

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

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 200 mg/25 mg Capsule Bottle Carton - NDC:

0573-0167-25

Advil® PM
LIQUIGELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

20
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 200 mg/25 mg Capsule Bottle Label

Advil® PM
LIQUIGELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

80
Liquid Filled
Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 200 mg/25 mg Capsule Bottle Carton - NDC:

0573-0167-55

Great
Value

Advil®
PM

LIQUIGELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

80
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 200 mg/25 mg Capsule Bottle Carton - NDC:

0573-0167-26

50%
MORE
FREE

10 Free
LIQUIGELS®

Advil® PM
LIQUIGELS®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

30
Liquid Filled
Capsules

INGREDIENTS AND APPEARANCE

ADVIL PM 
diphenhydramine hcl, ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0167
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0167-10	16 in 1 CARTON	12/20/2005	12/07/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0573-0167-20	32 in 1 CARTON	12/20/2005	12/07/2017
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0573-0167-21	40 in 1 CARTON	12/20/2005	12/07/2017
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0573-0167-25	1 in 1 CARTON	12/20/2005
4		20 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0573-0167-43	1 in 1 CARTON	12/20/2005
5		40 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0573-0167-55	1 in 1 CARTON	12/20/2005
6		80 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0573-0167-18	24 in 1 CARTON	12/20/2005	12/07/2017
7		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 0573-0167-19	24 in 1 CARTON	12/20/2005	12/07/2017
8		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC: 0573-0167-26	1 in 1 CARTON	12/20/2005
9		30 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 0573-0167-42	40 in 1 CARTON	12/20/2005	12/07/2017
10		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC: 0573-0167-44	1 in 1 CARTON	12/20/2005
11		50 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 0573-0167-56	1 in 1 CARTON	12/20/2005
12		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021393	12/20/2005

Labeler - Pfizer Consumer Healthcare (828831730)