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

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.

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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 or 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

label

NON-ASPIRIN PM EXTRA STRENGTH 
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code V15AV;S525;CPC752
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-017-5050 in 1 BOTTLE; Type 0: Not a Combination Product11/17/201106/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/17/201106/01/2016
Labeler - New World Imports, Inc (075372276)

Revised: 8/2017
Document Id: fee6093c-3585-4722-8406-371e7d27a5ee
Set id: 1406ab00-ef19-41b8-a7ef-789acf546152
Version: 4
Effective Time: 20170809
 
New World Imports, Inc