DrugCite

PAIN RELIEF PM EXTRA STRENGTH - acetaminophen and diphenhydramine hydrochloride tablet, coated 
AmerisourceBergen (Good Neighbor Pharmacy)

Extra Strength Acetaminophen PM

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep- aid

Uses

temporary relief of occasional headaches and minor aches and pains 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 products containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • a breathing problems 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 a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care 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. Quick 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 (see overdose warning)
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

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid high humidity and excessive heat

Inactive ingredients

croscarmellose sodium*, D&C yellow # 10 aluminium, lake*, FD&C blue #1 aluminium lake, FD&C blue #2 aluminium lake*, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, titanium dioxide, triacetin*

*contains one or more of these ingredients

Questions or comments?

call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

Compare to Extra Strength Tylenol®PM active ingredients**

EXTRA STRENGTH

Non- Habit forming 

Pain Relief PM

Acetaminophen 500 mg,

Diphenhydramine HCl 25 mg

Pain reliever /Nighttime Sleep-Aid

50 CAPLETS

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.


Good Neighbor Pharmacy

Pain Relief PM Caplets


PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 46122-179
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
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POVIDONES  
STEARIC ACID  
TITANIUM DIOXIDE  
D&C YELLOW NO. 10  
MAGNESIUM SILICATE  
MINERAL OIL  
STARCH, CORN  
SILICON DIOXIDE  
SODIUM STARCH GLYCOLATE TYPE A CORN  
TRIACETIN  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code S525;CPC752
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 46122-179-71 1 BOTTLE In 1 BOX contains a BOTTLE
1 50 TABLET In 1 BOTTLE This package is contained within the BOX (46122-179-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/23/2013

Labeler - AmerisourceBergen (Good Neighbor Pharmacy) (007914906)
Registrant - P and L Development of New York Corporation (800014821)
Revised: 04/2013AmerisourceBergen (Good Neighbor Pharmacy)