PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet, coated 
A&Z Pharmaceutical, 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 500mg

Diphenhydramine HCI 25mg

PURPOSES

Analgesic

Antihistamine

USES

temporarily relieves 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 4000 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

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you

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

When Using

  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery after use
  • avoid alcoholic drinks

Stop use and ask a doctor if

  • 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
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
  • You may report side effects to 888-952-0050

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

DIRECTIONS
Adults and children 12 years of age and older Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years of age Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

OTHER INFORMATION

  • store at room temperature
  • do no use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

croscarmellose sodium, FD&C Blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

PRINCIPAL DISPLAY PANEL

Product Label

Extra Strength

Pain Reliever/Sleep Aid

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

*Compare to active ingredients in Tylenol® PM

*Health A2Z® Extra Strength Pain Relief PM is not manufactured or distributed by McNeil Consumer Products Co., distributor of Tylenol® PM.

Mfg by: A&Z Pharmaceutical, Inc. 180 Oser Avenue Hauppauge, NY 11788

APAPPM24sLabel.jpg
PAIN RELIEF PM 
acetaminophen and diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-267
Route of AdministrationORALDEA Schedule    
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorblue ((Light Blue)) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code AZ267
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62211-267-501 in 1 BOX
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62211-267-02150 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:62211-267-011 in 1 BOX
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/20/200405/05/2015
Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIBusiness Operations
A&Z Pharmaceutical, Inc.926820705manufacture(62211-267)

Revised: 5/2015
Document Id: b2f66de2-a934-4daa-843a-1802a6052e90
Set id: c20de3a4-cbcd-457d-8ebe-6f72667779ac
Version: 2
Effective Time: 20150505
 
A&Z Pharmaceutical, Inc.