Thrulife Extra Strength Headache Relief
02fa9c00-214a-4289-8ab5-d470ce04a70f
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
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 aid
Description
(in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
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.
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)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Inactive Ingredients
Otc Questions Section
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
EXTRA STRENGTH HEADACHE RELIEF
Carton label PDP
EXTRA STRENGTH HEADACHE RELIEF
Ask A Doctor Before Use 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
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)
Purpose
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))
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Inactive Ingredients (Inactive ingredients)
Otc Questions Section (OTC - Questions section)
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
EXTRA STRENGTH HEADACHE RELIEF
Carton label PDP
EXTRA STRENGTH HEADACHE RELIEF
Ask A Doctor Before Use If (Ask a doctor before use if)
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)
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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:34.801596 · Updated: 2026-03-14T22:53:23.299879