MENSTRUAL RELIEF - acetaminophen,caffeine,pyrilamine 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, Caffeine, Diuretic, Pyrilamine Maleate, Antihistamine

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Purpose

Pain Reliever

Diuretic

Antihistamine

Uses

For the temporary relief of these symptoms associated with menstrual periods:

Warnings

SEE BOTTLE FOR ADDITIONAL WARNINGS AND PRODUCT INFORMATION.

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 a doctor or pharmacist before use if you are:

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 the recommended dose

Other Information

Inactive Ingredients

Carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, micro-crystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Velocity Pharma LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1f5a9653-figure-01

1f5a9653-figure-02

NDC: 76168-064-03 –20 COUNT

Enteric Coated to help prevent upset stomach

MENSTRUAL RELIEF 
acetaminophen,caffeine,pyrilamine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code CH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-064-0320 in 1 BOTTLE
11 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/01/2013
Labeler - Velocity Pharma (962198409)
Registrant - Velocity Pharma (962198409)

Revised: 10/2013
Document Id: 1f5a9653-ad96-4723-8ec2-4e0815495c66
Set id: cfc785c6-870f-45a7-86a5-d9b9de06dd8c
Version: 1
Effective Time: 20131023
 
Velocity Pharma