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Pain Reliever PM by HealthLife of USA

Dosage form: tablet
Ingredients: Acetaminophen 500mg, Diphenhydramine Hydrochloride 25mg
Labeler: HealthLife of USA
NDC Code: 69517-113

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.

Pain Relief PM - Acetaminophen and Diphenhydramine HCl

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid

Uses

temporary relief of 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 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 product containing diphenhydramine, even one used on skin 
  • 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
  • a breathing problem 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 serious underlying medical illness.
  • pain gets worse or lasts more than 10 days 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present 
  • new symptoms occur

These could be signs of a serious condition.

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

Keep out of reach of children.

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 (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 this adult 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 between 20-25°C (68-77°F)
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, fdc blue #1 aluminum lake, fdc blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium metabisulfite, sodium starch glycolate, stearic acid, titanium dioxide, talc

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol PM
®*

PAIN RELIEVER PM

Pain RelieverNighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

PAIN RELIEVER PM 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-113
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
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code131
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-113-2525 POUCH in 1 BOX
12 TABLET in 1 POUCH
2NDC:69517-113-5050 POUCH in 1 BOX
22 TABLET in 1 POUCH
3NDC:69517-113-022 POUCH in 1 POUCH
32 TABLET in 1 POUCH
4NDC:69517-113-101000 BOTTLE in 1 BOTTLE
4NDC:69517-113-05500 BOTTLE in 1 BOTTLE
4NDC:69517-113-3030 CARTON in 1 BOTTLE
41 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/09/2016
Labeler - HealthLife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceutical Ltd.915664486manufacture(69517-113)

 
HealthLife of USA

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Medically reviewed on Jun 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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