ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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 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 20 Coated Caplets
ADVIL PM 
diphenhydramine citrate and ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUE (blue) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0164-331 in 1 CARTON12/21/2005
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0164-044 in 1 POUCH; Type 0: Not a Combination Product12/21/2005
3NDC:0573-0164-201 in 1 CARTON12/21/2005
320 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0164-301 in 1 CARTON12/21/2005
440 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0164-401 in 1 CARTON12/21/2005
580 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0164-431 in 1 CARTON12/21/2005
6120 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0164-451 in 1 CARTON12/21/2005
7180 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0573-0164-321 in 1 CARTON12/21/2005
850 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0573-0164-411 in 1 CARTON12/21/2005
9100 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0573-0164-913000 in 1 BOX12/21/2005
102 in 1 POUCH; Type 0: Not a Combination Product
11NDC:0573-0164-052 in 1 CARTON12/21/2005
112 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0573-0164-5550 in 1 TRAY12/21/2005
122 in 1 POUCH; Type 0: Not a Combination Product
13NDC:0573-0164-211 in 1 CARTON12/21/2005
1330 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:0573-0164-441 in 1 CARTON12/21/2005
14140 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:0573-0164-142 in 1 CARTON12/21/2005
152 in 1 POUCH; Type 0: Not a Combination Product
16NDC:0573-0164-126 in 1 CARTON12/21/2005
162 in 1 POUCH; Type 0: Not a Combination Product
17NDC:0573-0164-491 in 1 CARTON12/21/2005
17200 in 1 BOTTLE; Type 0: Not a Combination Product
18NDC:0573-0164-461 in 1 CARTON12/21/2005
18180 in 1 BOTTLE; Type 0: Not a Combination Product
19NDC:0573-0164-65120 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2016
20NDC:0573-0164-081 in 1 PACKAGE03/17/2017
208 in 1 VIAL; Type 0: Not a Combination Product
21NDC:0573-0164-098 in 1 VIAL; Type 0: Not a Combination Product03/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139412/21/2005
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0164) , LABEL(0573-0164) , MANUFACTURE(0573-0164) , PACK(0573-0164)

Revised: 9/2021
Document Id: 1426af97-d267-4217-be0d-9626c70c4203
Set id: 658fc201-47c9-6a6d-8af9-6208298d43b4
Version: 16
Effective Time: 20210902
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC