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ADVIL PM by Pfizer Consumer Healthcare

Medically reviewed on December 8, 2017

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg, IBUPROFEN 200mg
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-0167

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

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
LIQUI•GELS®

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
LIQUI•GELS
®

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

LIQUI•GELS®

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
LIQUI•GELS®

Advil® PM
LIQUI•GELS®

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

30
Liquid Filled
Capsules

ADVIL PM 
diphenhydramine hcl, ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem 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 
GELATIN, UNSPECIFIED 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUE (Clear blue) Scoreno score
ShapeOVAL (Oval liqui-gel) Size15mm
FlavorImprint CodeAdvil;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0167-1016 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:0573-0167-2032 BLISTER PACK in 1 CARTON
21 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:0573-0167-2140 BLISTER PACK in 1 CARTON
31 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
4NDC:0573-0167-251 BOTTLE in 1 CARTON
420 CAPSULE, LIQUID FILLED in 1 BOTTLE
5NDC:0573-0167-431 BOTTLE in 1 CARTON
540 CAPSULE, LIQUID FILLED in 1 BOTTLE
6NDC:0573-0167-551 BOTTLE in 1 CARTON
680 CAPSULE, LIQUID FILLED in 1 BOTTLE
7NDC:0573-0167-1824 BLISTER PACK in 1 CARTON
71 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
8NDC:0573-0167-1924 BLISTER PACK in 1 CARTON
81 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
9NDC:0573-0167-261 BOTTLE in 1 CARTON
930 CAPSULE, LIQUID FILLED in 1 BOTTLE
10NDC:0573-0167-4240 BLISTER PACK in 1 CARTON
101 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
11NDC:0573-0167-441 BOTTLE in 1 CARTON
1150 CAPSULE, LIQUID FILLED in 1 BOTTLE
12NDC:0573-0167-561 BOTTLE in 1 CARTON
12100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139312/20/2005
Labeler - Pfizer Consumer Healthcare (828831730)

 
Pfizer Consumer Healthcare

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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