ADVIL PM- diphenhydramine hydrochloride and ibuprofen capsule, liquid filled 
Pfizer Consumer Healthcare

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Advil PM Liqui-Gels (diphenhydramine HCl and ibuprofen)

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 - 8 Capsule Blister Pack

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 - 16 Capsule Blister Pack Carton
ADVIL PM 
diphenhydramine hcl, ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0573-0167
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
MEDIUM-CHAIN TRIGLYCERIDES 
GELATIN 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUE (Clear blue) Scoreno score
ShapeOVAL (Oval liqui-gel) Size15mm
FlavorImprint Code Advil;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0167-102 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:0573-0167-204 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:0573-0167-215 in 1 CARTON
38 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139312/20/2005
Labeler - Pfizer Consumer Healthcare (828831730)

Revised: 1/2014
 
Pfizer Consumer Healthcare