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← See all Acetaminophen PM Extra Strength brands

Acetaminophen PM Extra Strength

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-210

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.

Quality Choice 44-556

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

  • 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.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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
  • 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
  • pain gets worse or lasts more than 10 days
  • 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
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

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

QC®
QUALITY
CHOICE 

NDC 63868-210-20

Compare to the active ingredients
in EXTRA STRENGTH
TYLENOL® PM*

Extra Strength
Acetaminophen PM

Acetaminophen 500 mg,
Diphenhydramine HCl 25 mg
Pain Reliever / Nighttime Sleep-Aid

Rapid Release Gelcaps

20 Gelcaps

Non-Habit Forming

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
Johnson & Johnson Corporation, owner of the registered
trademark Extra Strength Tylenol® PM.
50844      REV0417B55609

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300

Quality Choice 44-556

ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
GELATIN, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
AMMONIA 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;6
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-210-201 BOTTLE in 1 CARTON
120 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/17/2007
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63868-210)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(63868-210), PACK(63868-210)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63868-210)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63868-210)

 
CHAIN DRUG MARKETING ASSOCIATION INC

← See all Acetaminophen PM Extra Strength brands

Medically reviewed on Aug 16, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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