ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 
Pfizer Consumer Healthcare

----------

Advil PM (diphenhydramine citrate and ibuprofen)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSES

Nighttime sleep-aid

Pain reliever

USES

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

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

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

Advil®PM

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

20 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton

Advil®PM

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

20 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 4 Caplet Carton

COUPON INSIDE

for next purchase
of 16ct or larger

Advil®PM

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

4 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

PRINCIPAL DISPLAY PANEL - 4 Caplet Carton

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch

Advil®PM

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

2 Caplets

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch

PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

Advil®PM

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

Caplets

50 PACKETS OF 2 COATED CAPLETS*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 50 Pouch Tray
ADVIL PM 
diphenhydramine citrate and ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0573-0164
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
GLYCERYL DIBEHENATE 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0164-331 in 1 CARTON
150 in 1 BOTTLE; Combination Product Type = C112160
2NDC:0573-0164-044 in 1 POUCH; Combination Product Type = C112160
3NDC:0573-0164-201 in 1 CARTON
320 in 1 BOTTLE; Combination Product Type = C112160
4NDC:0573-0164-301 in 1 CARTON
440 in 1 BOTTLE; Combination Product Type = C112160
5NDC:0573-0164-401 in 1 CARTON
580 in 1 BOTTLE; Combination Product Type = C112160
6NDC:0573-0164-431 in 1 CARTON
6120 in 1 BOTTLE; Combination Product Type = C112160
7NDC:0573-0164-451 in 1 CARTON
7180 in 1 BOTTLE; Combination Product Type = C112160
8NDC:0573-0164-321 in 1 CARTON
850 in 1 BOTTLE; Combination Product Type = C112160
9NDC:0573-0164-411 in 1 CARTON
9100 in 1 BOTTLE; Combination Product Type = C112160
10NDC:0573-0164-913000 in 1 BOX
102 in 1 POUCH; Combination Product Type = C112160
11NDC:0573-0164-052 in 1 CARTON
112 in 1 BOTTLE; Combination Product Type = C112160
12NDC:0573-0164-5550 in 1 TRAY
122 in 1 POUCH; Combination Product Type = C112160
13NDC:0573-0164-211 in 1 CARTON
1330 in 1 BOTTLE; Combination Product Type = C112160
14NDC:0573-0164-441 in 1 CARTON
14140 in 1 BOTTLE; Combination Product Type = C112160
15NDC:0573-0164-142 in 1 CARTON
152 in 1 POUCH; Combination Product Type = C112160
16NDC:0573-0164-126 in 1 CARTON
162 in 1 POUCH; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139412/21/2005
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-0164), LABEL(0573-0164), MANUFACTURE(0573-0164), PACK(0573-0164)

Revised: 9/2014
Document Id: 8a1758ee-95d6-4a8b-bf7f-819c8132aad2
Set id: 658fc201-47c9-6a6d-8af9-6208298d43b4
Version: 7
Effective Time: 20140917
 
Pfizer Consumer Healthcare