ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated

Advil PM by

Drug Labeling and Warnings

Advil PM by is a Otc medication manufactured, distributed, or labeled by WYETH CONSUMER HEALTHCARE LLC, Exel Inc. dba DHL Supply Chain (USA). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

(IN EACH CAPLET)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Nighttime sleep-aid

Pain reliever

INACTIVE INGREDIENT

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​

DOSAGE & ADMINISTRATION

• 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

WARNINGS

STORAGE AND HANDLING

• 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)

INDICATIONS & USAGE

• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

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

50
Coated Caplets*
*Capsule-Shaped Tablets

INGREDIENTS AND APPEARANCE

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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue (C48333 - BLUE)	Score	no score
Shape	OVAL (C48345)	Size	15mm
Flavor		Imprint Code	Advil;PM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0164-34	1 in 1 CARTON	09/14/2018	09/14/2018
1		50 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 - WYETH CONSUMER HEALTHCARE LLC (828831730)

Registrant - Exel Inc. dba DHL Supply Chain (USA) (036235240)

Establishment
Name	Address	ID/FEI	Business Operations
Exel Inc. dba DHL Supply Chain (USA)		029119516	repack(0573-0164) , relabel(0573-0164)

Establishment
Name	Address	ID/FEI	Business Operations
WYETH CONSUMER HEALTHCARE LLC		828831730	manufacture(0573-0164) , label(0573-0164)