Pain Relief PM

Manufacturer: CVS Pharmacy | LNK International, Inc.
Effective date: 2017-03-13
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-02 01:17:45

Label at a glance#

ProductPain Relief PM

Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE CITRATE

Label structure9 sections

Indications and uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor children under 12 years: do not use

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever
Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 2 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Do not use

OTC - DO NOT USE SECTION

if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a breathing problem such as emphysema or chronic bronchitis
liver disease
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

drowsiness may occur
avoid alcoholic beverages
be careful when driving a motor vehicle or opening machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days
sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
fever gets worse or lasts more than 3 days
new symptoms occur
painful area is red or swollen

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)
adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health_™

Compare to the active
ingredients in Excedrin^® PM*

Coated Tablets

NDC 59779-373-12

Aspirin Free
PAIN RELIEF PM
ACETAMINOPHEN, 500 mg
DIPHENHYDRAMINE CITRATE, 38 mg

Pain reliever, Nighttime sleep-aid

• Non-habit forming
• For pain with sleeplessness

100 COATED TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Novartis Consumer
Health, Inc., owner of the registered trademark Excedrin^® PM.
50844 ORG041437312

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com^®
1-800-SHOP CVS
V-11112

CVS Quality
Money Back Guarantee

CVS 44-373

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1099872	Acetaminophen/diphenhydrAMINE (Oral Pill)	acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet	SCD Active

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0050428371596	GTIN-13: 0050428371596 EAN-13: 0050428371596 GTIN-12: 050428371596 UPC-A: 050428371596 GTIN storage (14 digits): 00050428371596	cvs-44-373-1.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	7
DIPHENHYDRAMINE CITRATE	ACTIVE INGREDIENT	4OD433S209	7
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	7
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

Pain Relief PM
Acetaminophen and Diphenhydramine Citrate
ACETAMINOPHEN
DIPHENHYDRAMINE CITRATE
DIPHENHYDRAMINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE
STARCH, CORN
CROSPOVIDONE, UNSPECIFIED
SHELLAC
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59779-373	59779-373-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
DIPHENHYDRAMINE CITRATE	4OD433S209	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSPOVIDONE, UNSPECIFIED	2S7830E561	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 338 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	GRANULE, FOR SUSPENSION / ORAL		282 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	GRANULE / ORAL		150 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / VAGINAL	28 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, COATED PELLETS / ORAL		198 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
90e7fd56-0c1d-4dce-8b85-271e484cee3b			b6c6f364-ce8b-4672-818b-2571dda1de06	2017-03-13	Warnings	Exact identifier spl id: 90e7fd56-0c1d-4dce-8b85-271e484cee3b spl set id: b6c6f364-ce8b-4672-818b-2571dda1de06

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.