ACETAMINOPHEN PM- acetaminophen, diphenhydramine hcl liquid

Acetaminophen PM by

Drug Labeling and Warnings

Acetaminophen PM by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

*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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN PM 
acetaminophen, diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-758
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY (Mixed)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-758-19	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2019

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	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(69842-758) , PACK(69842-758)