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Pain Relief PM by Velocity Pharma

Medically reviewed on August 25, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Velocity Pharma
NDC Code: 76168-011

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.

Acetaminophen, Diphenhydramine HCl Tablets

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

pain reliever/fever reducer

Nighttime sleep aid

Uses
  • temporarily 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 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). 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
  • With other products containing diphenhydramine, even one used on skin.

ask a doctor before use if you have

  • liver disease
  • asthma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • galucoma

ask your doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.

When using this product

  • avoid alcoholic drinks
  • 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 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.

Keep out of reach of children.

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

Directions
  • do not exceed recommended dose
  • 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 at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
  • 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, FD&C blue #1 aluminum lake, FD&C 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

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-011-04   24 COUNT

PAIN RELIEF PM 
acetaminophen pm tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-011
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 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM METABISULFITE 
STEARIC ACID 
TITANIUM DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
POLYETHYLENE GLYCOL 1000 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code131
Contains    
Packaging
#Item CodePackage Description
1NDC:76168-011-0424 CARTON (TABLET) in 1 BOTTLE
11 TABLET (BOTTLE) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/05/2012
Labeler - Velocity Pharma (962198409)

 
Velocity Pharma

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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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