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Name:Advil Pm
Manufacturer:Lil' Drug Store Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Advil® PM

ADVIL PM - ibuprofen and diphenhydramine citrate tablet, coated 
Lil' Drug Store Products, Inc.

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Advil® PM

Drug Facts

Active ingredient (in each tablet) Purposes
*
nonsteroidal anti-inflammatory drug
Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)*
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 caplets at bedtime
  • do not take more than 2 caplets in 24 hours

Other information

  • 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)

Inactive ingredients

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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

Repackaged and distributed with permission of Pfizer by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402
www.lildrugstore.com

PRINCIPAL DISPLAY PANEL - 4 COATED CAPLETS Carton

Advil® PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID) / Nighttime Sleep Aid

Caplets

See new warnings information

4 COATED
CAPLETS*

*Capsule-Shaped Tablets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 4 COATED CAPLETS Carton

ADVIL PM 
ibuprofen and diphenhydramine citrate tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9733(NDC:0573-0164)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 200 mg
Diphenhydramine citrate (Diphenhydramine) Diphenhydramine citrate 38 mg
Product Characteristics
Color BLUE Score no score
Shape OVAL (Capsule-Shaped, Smooth in texture w/ polish surface) Size 15mm
Flavor Imprint Code Advil;PM
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-9733-1 1 POUCH ( POUCH) in 1 CARTON contains a POUCH
1 2 TABLET, COATED ( TABLET) in 1 POUCH This package is contained within the CARTON (66715-9733-1)
2 NDC:66715-9733-2 2 POUCH ( POUCH) in 1 CARTON contains a POUCH
2 2 TABLET, COATED ( TABLET) in 1 POUCH This package is contained within the CARTON (66715-9733-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021394 05/11/2010

Labeler - Lil' Drug Store Products, Inc. (093103646)
Establishment
Name Address ID/FEI Operations
CCB Packaging Inc. 362374464 REPACK, RELABEL

Revised: 05/2010 Lil' Drug Store Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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