Thrulife Extra Strength Headache Relief
FDA Label NDC 52605-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Polygen Pharmaceuticals Llc for the product Thrulife Extra Strength Headache Relief (NDC 52605-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

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

Purpose

Pain relieverPain 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 20°-25°C (68°-77°F)
  • 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 PDPEXTRA STRENGTH HEADACHE RELIEFCarton label PDPEXTRA STRENGTH HEADACHE RELIEF

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