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Advil PM

Generic name: diphenhydramine citrate, ibuprofen
Dosage form: tablet, coated
Drug class: Analgesic combinations

Medically reviewed by Drugs.com. Last updated on Sep 1, 2021.

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 at 20 weeks or later in 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 ingredients

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 dibehenate, 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

Additional Information

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

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

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2021 GSK or licensor Trademarks owned or licensed by GSK

Principal Display Panel

NDC 0573-0164-20

Advil PM

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

20
Coated Caplets*
*Capsule-Shaped Tablets

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE 38 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
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
Color BLUE (blue) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Advil;PM
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0164-33 1 BOTTLE in 1 CARTON
1 50 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0164-04 4 TABLET, COATED in 1 POUCH
3 NDC:0573-0164-20 1 BOTTLE in 1 CARTON
3 20 TABLET, COATED in 1 BOTTLE
4 NDC:0573-0164-30 1 BOTTLE in 1 CARTON
4 40 TABLET, COATED in 1 BOTTLE
5 NDC:0573-0164-40 1 BOTTLE in 1 CARTON
5 80 TABLET, COATED in 1 BOTTLE
6 NDC:0573-0164-43 1 BOTTLE in 1 CARTON
6 120 TABLET, COATED in 1 BOTTLE
7 NDC:0573-0164-45 1 BOTTLE in 1 CARTON
7 180 TABLET, COATED in 1 BOTTLE
8 NDC:0573-0164-32 1 BOTTLE in 1 CARTON
8 50 TABLET, COATED in 1 BOTTLE
9 NDC:0573-0164-41 1 BOTTLE in 1 CARTON
9 100 TABLET, COATED in 1 BOTTLE
10 NDC:0573-0164-91 3000 POUCH in 1 BOX
10 2 TABLET, COATED in 1 POUCH
11 NDC:0573-0164-05 2 BOTTLE in 1 CARTON
11 2 TABLET, COATED in 1 BOTTLE
12 NDC:0573-0164-55 50 POUCH in 1 TRAY
12 2 TABLET, COATED in 1 POUCH
13 NDC:0573-0164-21 1 BOTTLE in 1 CARTON
13 30 TABLET, COATED in 1 BOTTLE
14 NDC:0573-0164-44 1 BOTTLE in 1 CARTON
14 140 TABLET, COATED in 1 BOTTLE
15 NDC:0573-0164-14 2 POUCH in 1 CARTON
15 2 TABLET, COATED in 1 POUCH
16 NDC:0573-0164-12 6 POUCH in 1 CARTON
16 2 TABLET, COATED in 1 POUCH
17 NDC:0573-0164-49 1 BOTTLE in 1 CARTON
17 200 TABLET, COATED in 1 BOTTLE
18 NDC:0573-0164-46 1 BOTTLE in 1 CARTON
18 180 TABLET, COATED in 1 BOTTLE
19 NDC:0573-0164-65 120 TABLET, COATED in 1 BOTTLE
20 NDC:0573-0164-08 1 VIAL in 1 PACKAGE
20 8 TABLET, COATED in 1 VIAL
21 NDC:0573-0164-09 8 TABLET, COATED in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021394 12/21/2005
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0164), LABEL(0573-0164), MANUFACTURE(0573-0164), PACK(0573-0164)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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