PAIN RELIEF PM- acetaminophen pm tablet 
Velocity Pharma

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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Acetaminophen, Diphenhydramine HCl Tablets

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

pain reliever/fever reducer

Nighttime sleep aid

Uses

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

do not use

ask a doctor before use if you have

ask your doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if:

Keep out of reach of children.

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

Directions

Other Information

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: 76168-119-25   50 COUNT

PM 50ct

PAIN RELIEF PM 
acetaminophen pm tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-119
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P525
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-119-2550 in 1 BOTTLE05/14/2018
11 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/05/2012
Labeler - Velocity Pharma (962198409)

Revised: 5/2018
Document Id: 6c30260f-b9e7-58c3-e053-2991aa0a818c
Set id: c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb
Version: 2
Effective Time: 20180514
 
Velocity Pharma