THRULIFE EXTRA STRENGTH HEADACHE RELIEF - acetaminophen, aspirin, caffeine tablet 
Polygen Pharmaceuticals LLC

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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THRULIFE EXTRA STRENGTH HEADACHE RELIEF

Active ingredient(s)

(in each caplet)                                  
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Use(s)

temporarily relieves minor headaches and pains due to: ●headache ● muscular aches ● premenstrual & menstrual cramps ● cold● sinusitis ● arthritis ● toothache

Warnings

Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Liver Warning: This product contains acetaminophen.

Severe liver damage may occur if you take · more than 8 tablets in 24 hours, which is the maximum daily amount · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ·are age 60 or older ·have had stomach ulcers or bleeding problems · take a  blood thinning (anticoagulant) or steroid drug ·take other drugs containing prescription or nonprescription NSAIDs ( aspirin, ibuprofen, naproxen, or others) ·have 3 or more alcoholic drinks every day while using this product ·take more or for a longer time than directed.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

Ask a doctor before use if

·you have liver disease ·stomach bleeding warning applies to you ·you have a history of stomach problems, such as heart burn ·you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ·you are taking a diuretic ·you have asthma

Ask a doctor or pharmacist before use if

Stop use and ask doctor if

  · feel faint · vomit blood · have bloody or black stools ·have stomach pain that does not get   better.

●pain gets worse or lasts for more than 10 days ● fever gets worse or lasts for more than 3 days

Pregnancy/Breastfeeding

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a

doctor because it may cause problems in the unborn child or  complications during delivery.

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

Other information

Inactive ingredients

Microcrystalline cellulose, Croscarmellose sodium, Stearic acid, Hypromellose, Traicetin, Titanium dioxide & Talc

Dosage & Administration section

OTC - Questions section

1-888-291-7337

Principal Display Panel

Bottle label PDP

EXTRA STRENGTH HEADACHE RELIEF

Bottle Label PDP




Carton label PDP

EXTRA STRENGTH HEADACHE RELIEF

Carton label PDP


THRULIFE EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-014-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34301/31/2013
Labeler - Polygen Pharmaceuticals LLC (962415720)
Establishment
NameAddressID/FEIBusiness Operations
Polygen Pharmaceuticals LLC962415720RELABEL(52605-014) , REPACK(52605-014) , MANUFACTURE(52605-014) , PACK(52605-014)

Revised: 12/2012
Document Id: 381cb51a-04d7-4f8c-b572-613d9cae3425
Set id: 02fa9c00-214a-4289-8ab5-d470ce04a70f
Version: 4
Effective Time: 20121212
 
Polygen Pharmaceuticals LLC