THRULIFE EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet

THRULIFE EXTRA STRENGTH HEADACHE RELIEF by

Drug Labeling and Warnings

THRULIFE EXTRA STRENGTH HEADACHE RELIEF by is a Otc medication manufactured, distributed, or labeled by Polygen Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• hives · facial swelling ·asthma (wheezing) · shock

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

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ·with any other drug containing acetaminophen (prescription or nonprescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

• a prescription drug fordiabetes,  gout,  arthritis
• any other drug containing an NSAID (prescription or nonprescription) · a blood thinning (anticoagulant)  or steroid drug  ·any other drug, or are under a doctor’s care for any serious condition.

Stop use and ask doctor if

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:

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

• painful area is red or swollen
• any few  symptoms appear ·ringing in the ears or loss of hearing occurs.

●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

• do not use more than directed ·drink a full glass of water with each dose ·adults and children 12 years and over: take 2 caplets every 6 hours: not more than 8 caplets in 24 hours ·
• children under  12 years of age: ask a doctor.

Other information

• store at controlled room temperature 20º-25ºC (68º-77ºF)
• read all product information before using.
• use by expiration date on package

Inactive ingredients

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

Dosage & Administration section

• Adults and children 12 years and over: Take 2 caplets every 6 hours; not more than 8 caplets in 24 hours.
• Children under 12 years: ask a doctor

OTC - Questions section

1-888-291-7337

Principal Display Panel

Bottle label PDP

EXTRA STRENGTH HEADACHE RELIEF

Carton label PDP

EXTRA STRENGTH HEADACHE RELIEF

INGREDIENTS AND APPEARANCE

THRULIFE EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52605-014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52605-014-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	01/31/2013

Labeler - Polygen Pharmaceuticals LLC (962415720)

Establishment
Name	Address	ID/FEI	Business Operations
Polygen Pharmaceuticals LLC		962415720	RELABEL(52605-014) , REPACK(52605-014) , MANUFACTURE(52605-014) , PACK(52605-014)