ADVIL PM

Pfizer Consumer Healthcare

Advil PM Liqui-Gels (diphenhydramine HCl and ibuprofen)

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENTS (IN EACH CAPSULE)
• PURPOSES
• USES
• WARNINGS
  • Allergy alert:
  • Stomach bleeding warning:
  • Do not use
  • Ask a doctor before use if
  • 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,
  • Keep out of reach of children.
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS OR COMMENTS?
• PRINCIPAL DISPLAY PANEL - 8 Capsule Blister Pack
• PRINCIPAL DISPLAY PANEL - 16 Capsule Blister Pack Carton
• PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label
• PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Carton

FULL PRESCRIBING INFORMATION

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

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, or asthma
• 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• 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, fractionated coconut oil, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

QUESTIONS OR COMMENTS?

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

PRINCIPAL DISPLAY PANEL - 8 Capsule Blister Pack

See warnings before use
Advil ^® PM
LIQUI-GELS®
Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Do Not Use if foil barrier is broken.
Dist. by: Pzifer, Madison, NJ 07940 USA

AREA FOR EXP. & LOT

SEPARATE FIRST

PEEL & PUSH

PRINCIPAL DISPLAY PANEL - 16 Capsule Blister Pack Carton

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Advil ^® PM
LIQUI-GELS ^®

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

16 Liqui-Gels^®*
*Liquid Filled Capsules

Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

Advil ^® PM
LIQUI-GELS ^®

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

80 Liquid Filled
Capsules

Liquid Filled
Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Carton

NEW!

Larger
Size

Advil ^® PM
LIQUI-GELS ^®

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

80 Liqui-Gels^®*
*Liquid Filled Capsules

Liquid Filled
Capsules