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 caplet)Purposes
*
nonsteroidal anti-inflammatory drug
Diphenhydramine citrate 38 mgNighttime sleep-aid
Ibuprofen 200 mg (NSAID)*Pain reliever

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

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

Other information

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 Consumer Healthcare by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 4 COATED CAPLETS Carton

Advil® PM

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

Caplets

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66715-9733(NDC:0573-0164)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Diphenhydramine citrate (Diphenhydramine) Diphenhydramine citrate38 mg
Inactive Ingredients
Ingredient NameStrength
calcium stearate 
carnauba wax 
silicon dioxide 
starch, corn 
croscarmellose sodium 
FD&C blue no. 2 
aluminum oxide 
glyceryl dibehenate 
hypromelloses 
lactose monohydrate 
cellulose, microcrystalline 
polydextrose 
polyethylene glycols 
sodium lauryl sulfate 
stearic acid 
titanium dioxide 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (Capsule-Shaped, Smooth in texture w/ polish surface) Size15mm
FlavorImprint Code Advil;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9733-22 in 1 CARTON
12 in 1 POUCH
2NDC:66715-9733-85 in 1 CARTON
22 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139405/11/2010
Labeler - Lil' Drug Store Products, Inc. (093103646)
Establishment
NameAddressID/FEIBusiness Operations
CCB Packaging Inc.362374464REPACK(66715-9733), RELABEL(66715-9733)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Consumer Healthcare828831730LABEL(66715-9733)

Revised: 12/2012
Document Id: f944ec73-8742-404c-8b33-1f8c4fd27e95
Set id: b876bb40-a38b-445a-bc8a-466b3bfe166d
Version: 2
Effective Time: 20121227
 
Lil' Drug Store Products, Inc.