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Advil PM by Navajo Manufacturing Company Inc.

Medically reviewed on Sep 20, 2018

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE CITRATE 38mg, IBUPROFEN 200mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-147

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Advil PM

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 • rash • skin reddening • 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 the 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 toll free 1-800-88-ADVIL

Package Labeling:

ADVIL PM 
diphenhydramine citrate, ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-147(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 
ALUMINUM OXIDE 
GLYCERYL DIBEHENATE 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize15mm
FlavorImprint CodeAdvil;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-147-011 POUCH in 1 CARTON
12 TABLET in 1 POUCH
2NDC:67751-147-022 POUCH in 1 CARTON
24 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/16/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

 
Navajo Manufacturing Company Inc.

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Further information

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

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