DrugCite

NON-ASPIRIN PM EXTRA STRENGTH  - acetaminophen and diphenhydramine hydrochloride tablet, coated 
New World Imports, Inc

Extra Strength Pain Relief 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, minor aches, and pains accompanying sleeplessness.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take:

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose warning: Taking more than the recommended done (overdose) may cause liver damage. In case of 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 children even if you do not notice any signs or symptoms.


Do not use

  • with other products 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 other products containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

  • liver disease
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery. This product will cause drowsiness.

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 for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breast-feeding, ask a health care professional before use.

Keep  out of reach of children.

Directions

  • do not exceed recommended dose
  • adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours.
  • children under 12 years of age: do not use this 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 at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
  • do not use if imprinted safety seal under cap is broken or missing
  • **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered
    trademark Tylenol® PM

Inactive ingredients

colloidal silicon dioxide*, croscarmellose sodium*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol*, povidone, pregelatinized starch, silica*, *purified water, *sodium metabisulfate, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*may also contain

Product Labeling

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

SEE NEW WARNINGS INFORMATION

Non-Aspirin PM Extra Strength

Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

Pain reliever /
Nighttime Sleep-Aid

50 CAPLETS


You may report serious side effects to:
Distributed by NWI, Inc.
160 Athens Way
Nashville, TN 37228

Pain Relief PM


NON-ASPIRIN PM EXTRA STRENGTH 
acetaminophen, diphenhydramine hcl  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 51824-017
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  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
POVIDONE  
SILICON DIOXIDE  
SODIUM STARCH GLYCOLATE TYPE A CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code V15AV;S525;CPC752
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 51824-017-50 50 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/17/2011

Labeler - New World Imports, Inc (075372276)
Revised: 06/2012New World Imports, Inc