DrugCite

ACETAMINOPHEN PM - acetaminophen and diphenhydramine hydrochloride tablet, coated 
AAA Pharmaceutical, Inc.

Acetaminophen PM

Drug Facts

Active ingredients
(in each caplet)
Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg 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

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged 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 drinks
  • 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 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.

Overdose warning

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

Directions

adults and children 12 years and over
  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours
children under 12 years
  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • store between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton

RESTORE u

NDC 57344-095-03

COMPARE TO THE
ACTIVE INGREDIENTS
IN TYLENOL® PM

EXTRA
STRENGTH

Non-habit forming

Pain Relief PM

Pain Reliever, Nighttime Sleep Aid

Acetaminophen
Diphenhydramine HCI

100 CAPLETS

Principal Display Panel - 100 Caplet Bottle Carton

ACETAMINOPHEN PM 
acetaminophen and diphenhydramine hydrochloride  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-095
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
SILICON DIOXIDE  
COPOVIDONE K25-31  
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
HYPROMELLOSES  
LACTOSE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POVIDONES  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code AAA;1031
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-095-01 1  In 1 CARTON contains a BOTTLE, PLASTIC
1 24  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-095-01)
2 57344-095-02 1  In 1 CARTON contains a BOTTLE, PLASTIC
2 50  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-095-02)
3 57344-095-03 1  In 1 CARTON contains a BOTTLE, PLASTIC
3 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-095-03)
4 57344-095-04 150  In 1 BOTTLE, PLASTIC None
5 57344-095-06 500  In 1 BOTTLE, PLASTIC None
6 57344-095-07 1000  In 1 BOTTLE, PLASTIC None
7 57344-095-08 100  In 1 BOTTLE, PLASTIC None
8 57344-095-09 2  In 1 CARTON contains a BOTTLE, PLASTIC
8 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-095-09)
9 57344-095-12 300  In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 12/13/2012

Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
Name Address ID/FEI Operations
AAA Pharmaceutical, Inc. 181192162 MANUFACTURE
Establishment
Name Address ID/FEI Operations
AAA Pharmaceutical, Inc. 010411533 PACK
Revised: 12/2012AAA Pharmaceutical, Inc.