Extra Strength Headache Relief Tablet
FDA Label NDC 29485-6486

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Extra Strength Headache Relief (NDC 29485-6486). 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 otc - purpose, use, reye's syndrome, allergy alert:, liver warning, stomach bleeding warning, caffeine warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredient (in each tablet)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Aspirin (NSAID)* 250 mgPain reliever/fever reducer
Caffeine 65 mgPain reliever aid

* nonsteroidal anti-inflammatory drug

Use

temporarily relieves minor aches and pains due to:

backache
headaches
colds
muscular aches
minor arthritis pain
menstrual cramps
Temporarily reduces fever.

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 behaviour 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


    • Allergy alert:

    acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.

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 (perscription or nonperscription). If you are not sure wether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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]
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

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, iritability, sleeplessness, and occasionally rapid heart beat.

Do Not Use

  • if you are allergic to aspirin or any other pain reliever / fever reducer
  • with any other pain reliever/fever reducer
    • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
    • if you have ever had an allergic reaction to any other pain reliever-fever reducer
    • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

Ask A Doctor Before Using If:

  • you have liver disease
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems (such as heartburn, upset stomach or stomach pain) 
  • you have high blood pressure, heart, liver or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug For

  • anticoagulation (thinning of blood)
  • diabetes
  • gout
  • arthritis

    • When using this product do not exceed recommended dose.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If:

  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs
  • pain or fever persists or gets worse
  • new symptoms occur
  • redness or swelling is present
  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

Otc - 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(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • adults and children 12 years of age and older:
    2 tablets as needed for pain every 6 hours.
    Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: consult a doctor

Other Information

  • TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN, CUT OR OPENED
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive Ingredients

Hydroxypropyl Methylcellulose*, Maltodextrin*, Microcrystalline Cellulose, Polyethylene Glycol*, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide*

*contains one or more of these ingredients

Questions Or Comments?

1-844-428-2538

Other

Manufactured by Ultratab Laboratories, Inc

Repackaged and distributed by
Convenience Valet®, Glendale Heights, IL 60139

* Please review the disclaimer below.