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THRULIFE EXTRA STRENGTH HEADACHE RELIEF

Polygen Pharmaceuticals LLC

THRULIFE EXTRA STRENGTH HEADACHE RELIEF

FULL PRESCRIBING INFORMATION: CONTENTS*

Active ingredient(s)
Purpose
Use(s)
Warnings
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if
Stop use and ask doctor if
Pregnancy/Breastfeeding
Keep out of reach of children
Directions
THRULIFE EXTRA STRENGTH HEADACHE RELIEF Other information
Inactive ingredients
Dosage & Administration section
OTC - Questions section
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FULL PRESCRIBING INFORMATION

Active ingredient(s)

(in each caplet)

Purpose

Use(s)

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

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

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.