OTC Medication Information: Acetaminophen PM Extra Strength

ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each gelcap)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

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

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 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

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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.

  • new symptoms occur
  • redness or swelling is present

  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 use

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

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 yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

CVS
Health

Compare to the active ingredients
in Extra Strength Tylenol® PM*

Gelcaps

NDC 69842-956-13

EXTRA STRENGTH

Acetaminophen PM
DIPHENHYDRAMINE HCI, 25 mg
ACETAMINOPHEN, 500 mg

Pain reliever,
Nighttime sleep aid

Non-habit forming

RAPID
RELEASE

Actual Size

250 GELCAPS

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

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

50844 ORG041755613

Distributed by: CVS Pharmacy,
Inc., One CVS Drive, Woonsocket,
RI 02895 © 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVSV-11112

CVS Health 44-596
(click image for full-size original)

CVS Health 44-596

ACETAMINOPHEN PM EXTRA STRENGTH acetaminophen, diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-956
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
DIMETHICONE
STEARIC ACID
TITANIUM DIOXIDE
STARCH, CORN
SHELLAC
Product Characteristics
Color BLUE (light) , BLUE (Dark) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code L;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-956-09 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 20 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (69842-956-09)
2 NDC:69842-956-13 250 TABLET in 1 BOTTLE None
3 NDC:69842-956-31 80 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 12/17/2007
Labeler — CVS Pharmacy (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 MANUFACTURE (69842-956), PACK (69842-956)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 PACK (69842-956)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (69842-956)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (69842-956)

Revised: 01/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.