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

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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

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

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

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Carton

Advil®PM

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

20
Coated Caplets*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle 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

Coated Caplets*
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

Advil®
PM

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

Two 2 Count Packets

4
Coated Caplets*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton
ADVIL PM 
diphenhydramine citrate and ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0164
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE (UNII: 776XM7047L)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE (blue) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Advil;PM
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0573-0164-33 1 in 1 CARTON 12/21/2005
1 50 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0573-0164-04 4 in 1 POUCH; Type 0: Not a Combination Product 12/21/2005
3 NDC:0573-0164-20 1 in 1 CARTON 12/21/2005
3 20 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0573-0164-30 1 in 1 CARTON 12/21/2005
4 40 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0573-0164-40 1 in 1 CARTON 12/21/2005
5 80 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0573-0164-43 1 in 1 CARTON 12/21/2005
6 120 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0164-45 1 in 1 CARTON 12/21/2005
7 180 in 1 BOTTLE; Type 0: Not a Combination Product
8 NDC:0573-0164-32 1 in 1 CARTON 12/21/2005
8 50 in 1 BOTTLE; Type 0: Not a Combination Product
9 NDC:0573-0164-41 1 in 1 CARTON 12/21/2005
9 100 in 1 BOTTLE; Type 0: Not a Combination Product
10 NDC:0573-0164-91 3000 in 1 BOX 12/21/2005
10 2 in 1 POUCH; Type 0: Not a Combination Product
11 NDC:0573-0164-05 2 in 1 CARTON 12/21/2005
11 2 in 1 BOTTLE; Type 0: Not a Combination Product
12 NDC:0573-0164-55 50 in 1 TRAY 12/21/2005
12 2 in 1 POUCH; Type 0: Not a Combination Product
13 NDC:0573-0164-21 1 in 1 CARTON 12/21/2005
13 30 in 1 BOTTLE; Type 0: Not a Combination Product
14 NDC:0573-0164-44 1 in 1 CARTON 12/21/2005
14 140 in 1 BOTTLE; Type 0: Not a Combination Product
15 NDC:0573-0164-14 2 in 1 CARTON 12/21/2005
15 2 in 1 POUCH; Type 0: Not a Combination Product
16 NDC:0573-0164-12 6 in 1 CARTON 12/21/2005
16 2 in 1 POUCH; Type 0: Not a Combination Product
17 NDC:0573-0164-49 1 in 1 CARTON 12/21/2005
17 200 in 1 BOTTLE; Type 0: Not a Combination Product
18 NDC:0573-0164-46 1 in 1 CARTON 12/21/2005
18 180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021394 12/21/2005
Labeler - Pfizer Consumer Healthcare (828831730)

Revised: 10/2016
Document Id: 4ec2d96b-1ed3-4cd6-bfe2-e318eaf70089
Set id: 658fc201-47c9-6a6d-8af9-6208298d43b4
Version: 10
Effective Time: 20161020
 
Pfizer Consumer Healthcare