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ADVIL PM by Wyeth Consumer Healthcare LLC

Medically reviewed on December 15, 2017

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE CITRATE 38mg, IBUPROFEN 200mg
Labeler: Wyeth Consumer Healthcare LLC
NDC Code: 0573-0164

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
  • 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

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
  • 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

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 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 - 50 Caplet Bottle Label

Advil®PM

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

50
Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

25%
MORE
FREE

Advil®PM

10 Free
Caplets

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

50
Coated Caplets*

*Capsule-Shaped Tablets

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 - 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 - 120 Caplet Bottle Label

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Useā„ 

CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®PM

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

120
Coated Caplets*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 8 Caplet Vial - Packed

Advil®PM

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

8
Caplets

PRINCIPAL DISPLAY PANEL - 8 Caplet Vial Package

Home &
Travel

Advil®PM

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

Do not use if blister is open or the words
"ADVIL SAFETY SEALED" under blister
are missing or torn.

8
Coated Caplets*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 8 Caplet Vial - Loose

Advil®PM

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

8
Coated Caplets*

*Capsule-Shaped Tablets

ADVIL PM 
diphenhydramine citrate and ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem 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 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (blue) Scoreno score
ShapeOVALSize15mm
FlavorImprint CodeAdvil;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0164-331 BOTTLE in 1 CARTON
150 TABLET, COATED in 1 BOTTLE
2NDC:0573-0164-044 TABLET, COATED in 1 POUCH
3NDC:0573-0164-201 BOTTLE in 1 CARTON
320 TABLET, COATED in 1 BOTTLE
4NDC:0573-0164-301 BOTTLE in 1 CARTON
440 TABLET, COATED in 1 BOTTLE
5NDC:0573-0164-401 BOTTLE in 1 CARTON
580 TABLET, COATED in 1 BOTTLE
6NDC:0573-0164-431 BOTTLE in 1 CARTON
6120 TABLET, COATED in 1 BOTTLE
7NDC:0573-0164-451 BOTTLE in 1 CARTON
7180 TABLET, COATED in 1 BOTTLE
8NDC:0573-0164-321 BOTTLE in 1 CARTON
850 TABLET, COATED in 1 BOTTLE
9NDC:0573-0164-411 BOTTLE in 1 CARTON
9100 TABLET, COATED in 1 BOTTLE
10NDC:0573-0164-913000 POUCH in 1 BOX
102 TABLET, COATED in 1 POUCH
11NDC:0573-0164-052 BOTTLE in 1 CARTON
112 TABLET, COATED in 1 BOTTLE
12NDC:0573-0164-5550 POUCH in 1 TRAY
122 TABLET, COATED in 1 POUCH
13NDC:0573-0164-211 BOTTLE in 1 CARTON
1330 TABLET, COATED in 1 BOTTLE
14NDC:0573-0164-441 BOTTLE in 1 CARTON
14140 TABLET, COATED in 1 BOTTLE
15NDC:0573-0164-142 POUCH in 1 CARTON
152 TABLET, COATED in 1 POUCH
16NDC:0573-0164-126 POUCH in 1 CARTON
162 TABLET, COATED in 1 POUCH
17NDC:0573-0164-491 BOTTLE in 1 CARTON
17200 TABLET, COATED in 1 BOTTLE
18NDC:0573-0164-461 BOTTLE in 1 CARTON
18180 TABLET, COATED in 1 BOTTLE
19NDC:0573-0164-65120 TABLET, COATED in 1 BOTTLE
20NDC:0573-0164-081 VIAL in 1 PACKAGE
208 TABLET, COATED in 1 VIAL
21NDC:0573-0164-098 TABLET, COATED in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139412/21/2005
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0164), LABEL(0573-0164), MANUFACTURE(0573-0164), PACK(0573-0164)

 
Wyeth Consumer Healthcare LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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