Thrulife Extra Strength Headache Relief

Thrulife Extra Strength Headache Relief
SPL v4
SPL
SPL Set ID 02fa9c00-214a-4289-8ab5-d470ce04a70f
Route
ORAL
Published
Effective Date 2012-12-07
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Caffeine (65 mg) Aspirin
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Stearic Acid Hypromelloses Titanium Dioxide Triacetin Talc

Identifiers & Packaging

Pill Appearance
Imprint: P14 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-31

Description

(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


Medication Information

Purpose
Pain reliever

Pain reliever

Pain reliever aid

Description

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

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.

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.
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.
Other Information
  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • read all product information before using.
  • use by expiration date on package
Active Ingredient(s)
(in each caplet)                                  

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients
Microcrystalline cellulose, Croscarmellose sodium, Stearic acid, Hypromellose, Traicetin, Titanium dioxide & Talc
Otc Questions Section
1-888-291-7337
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.

Principal Display Panel
Bottle label PDP



EXTRA STRENGTH HEADACHE RELIEF











Carton label PDP



EXTRA STRENGTH HEADACHE RELIEF







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
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

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.
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
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.

Structured Label Content

Use(s)
temporarily relieves minor headaches and pains due to: ●headache ● muscular aches ● premenstrual & menstrual cramps ● cold● sinusitis ● arthritis ● toothache
Purpose
Pain reliever

Pain reliever

Pain reliever aid

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.

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.
Do Not Use (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.
Other Information (Other information)
  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • read all product information before using.
  • use by expiration date on package
Active Ingredient(s) (Active ingredient(s))
(in each caplet)                                  

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)
Microcrystalline cellulose, Croscarmellose sodium, Stearic acid, Hypromellose, Traicetin, Titanium dioxide & Talc
Otc Questions Section (OTC - Questions section)
1-888-291-7337
Pregnancy/breastfeeding (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.

Principal Display Panel
Bottle label PDP



EXTRA STRENGTH HEADACHE RELIEF











Carton label PDP



EXTRA STRENGTH HEADACHE RELIEF







Ask A Doctor Before Use If (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
Stop Use and Ask Doctor If (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

Keep Out of Reach of Children (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.
Dosage & Administration Section (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
Ask A Doctor Or Pharmacist 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.

Advanced Ingredient Data


Raw Label Data

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