DailyMed - ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

NDC Code(s): 69842-956-09, 69842-956-13, 69842-956-31
Packager: CVS PHARMACY

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 25, 2025

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Active ingredients (in each gelcap)
Acetaminophen 500 mg - Diphenhydramine HCl 25 mg

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

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Purpose
Pain reliever - Nighttime sleep-aid

Pain reliever
Nighttime sleep-aid

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

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

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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - with other drugs containing acetaminophen - more than 4,000 mg of acetaminophen in 24 hours - 3 or ...
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- 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.
- any new symptoms appear
- redness or swelling is present
- fever gets worse or lasts more than 3 days
If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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Directions
do not take more than directed - adults and children 12 years and over - take 2 gelcaps at bedtime - do not take more than 2 gelcaps of this product in 24 hours - children under 12 years: do not ...
- do not take more than directed
- adults and children 12 years and over
  - take 2 gelcaps at bedtime
  - do not take more than 2 gelcaps of this product in 24 hours
- children under 12 years: do not use
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Other information
avoid high humidity - store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
- avoid high humidity
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
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Inactive ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide ...

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal display panel
CVS™ actual size - Extra Strength - ACETAMINOPHEN PM - Acetaminophen, 500 mg - Diphenhydramine HCl, 25 mg - Pain Reliever, Nighttime Sleep-Aid - Compare to Tylenol® PM - Extra Strength active ...

CVS™

actual size

Extra Strength
ACETAMINOPHEN PM
Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg
Pain Reliever, Nighttime Sleep-Aid

Compare to Tylenol® PM
Extra Strength active ingredients*
80 GELCAPS

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

*This product is not manufactured or distributed by Kenvue Inc., owner of the
registered trademark Tylenol® PM Extra Strength.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-11112
50844
ORG032455631

CVS 44-556

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INGREDIENTS AND APPEARANCE

Product Information

ACETAMINOPHEN PM EXTRA STRENGTH acetaminophen, diphenhydramine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-956
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIA (UNII: 5138Q19F1X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (light) , blue (Dark)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	L;6
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-956-31	80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2007
2	NDC:69842-956-09	1 in 1 CARTON	12/17/2007	08/31/2023
2		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:69842-956-13	250 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2007	11/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	12/17/2007

Labeler - CVS PHARMACY (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	manufacture(69842-956) , pack(69842-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(69842-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(69842-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(69842-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(69842-956)

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Published Date (What is this?)	Version	Files
Mar 27, 2025	11 (current)	download
Sep 6, 2024	10	download
Jan 29, 2024	9	download
Oct 9, 2023	8	download
Jan 18, 2023	7	download
Jan 7, 2022	6	download
Jan 6, 2021	5	download
Jan 31, 2020	4	download
Jan 24, 2020	3	download
May 1, 2019	2	download
Apr 5, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
2	1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD
3	1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY

Label: ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	69842-956-09
2	69842-956-13
3	69842-956-31

Label: ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

Number of versions: 11

ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

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ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.