Advil PM Liqui-Gels

Generic Name: diphenhydramine hydrochloride, ibuprofen
Dosage Form: capsule, liquid filled

Advil PM Liqui-Gels (diphenhydramine HCl and ibuprofen)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPSULE)

Diphenhydramine hydrochloride 25 mg

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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 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 the reach of children.

In case of medical 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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil PM

LIQUI-GELS

Solubilized Ibuprofen, 200 mg / Diphenhydramine HCl, 25 mg

Pain Reliever (NSAID) / Nighttime Sleep-Aid

32 Liqui-Gels*

*Liquid Filled Capsules

See new warnings information

Read and Keep Carton for Complete Warnings and Information

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

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

Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

U.S. Patent Pending

LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diphenhydramine hydrochloride (diphenhydramine) diphenhydramine hydrochloride 25 mg
ibuprofen (ibuprofen) ibuprofen 200 mg
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
1 NDC:0573-0167-10 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 8 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
2 NDC:0573-0167-20 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 8 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021393 12/20/2005
Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 01/2010
 
Wyeth Consumer Healthcare



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