OTC Medication Information: Acetaminophen PM

ACETAMINOPHEN PM- acetaminophen and diphenhydramine hydrochloride solution
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 30 mL dose cup)

Acetaminophen 1,000 mg
Diphenhydramine HCl 50 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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

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

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present
  • new symptoms occur

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

  • mL = milliliter; FL OZ = fluid ounce

  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

  • adults and children 12 years and over: take 30 mL in the dosing cup provided at bedtime. Do not take more than 30 mL of this product in 24 hours.

  • children under 12 years: do not use

Other information

  • each 30 mL dose cup contains: sodium 11 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose

Questions or comments?

1-800-426-9391

Principal display panel

CVS
Health

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

Liquid

EXTRA STRENGTH
Acetaminophen PM
ACETAMINOPHEN, 1000 mg
DIPHENHYDRAMINE HCl, 50 mg

Pain reliever/
Nighttime sleep aid

Alcohol free

8 FL OZ (237 mL)

Mixed Berry

F-058-19

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

50844 ORG091805819

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com®1-800-SHOP CVS V-11112

CVS 44-058
(click image for full-size original)

CVS 44-058

ACETAMINOPHEN PM acetaminophen, diphenhydramine hcl solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 1000 mg in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM METABISULFITE
SACCHARIN SODIUM
SUCRALOSE
Product Characteristics
Color blue Score
Shape Size
Flavor BERRY (Mixed) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-758-19 237 mL 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 01/12/2019
Labeler — CVS PHARMACY (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 manufacture (69842-758), pack (69842-758)

Revised: 09/2021 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.