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

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

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

e0595668-figure-01

e0595668-figure-02

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 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 131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-011-0424 in 1 BOTTLE
11 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)

Revised: 8/2013
Document Id: e0595668-bbee-4f87-92cb-2a987105d2c0
Set id: 1a49129b-381d-4be4-baa1-c1ba5f00b312
Version: 1
Effective Time: 20130825
 
Velocity Pharma