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Pain Relief PM by Avema Pharma Solutions

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Avema Pharma Solutions
NDC Code: 63548-0065

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.

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


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

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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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
  • do not take more than directed
  • 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 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 ingredientscolloidal silicon dioxide*, croscarmellose sodium*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol,
polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*contains one or more of these ingredients

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


EXTRA STRENGTH

Pain Relief PM

Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

Pain reliever /
Nighttime Sleep-Aid

24 CAPLETS


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


PAIN RELIEF PM 
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0065
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScoreno score
ShapeCAPSULESize7mm
FlavorImprint CodeV15AV;S525;CPC752
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-0065-11 BOTTLE (BOTTLE) in 1 BOX
124 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/14/2012
Labeler - Avema Pharma Solutions (804087794)

Revised: 05/2012
 
Avema Pharma Solutions

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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