Tension Headache Relief Tablet
FDA Label NDC 0363-7213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Tension Headache Relief (NDC 0363-7213). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Purpose

Active ingredients (in each caplet)Purposes
 Acetaminophen 500 mg Pain reliever
 Caffeine 65 mg Pain reliever aid

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches

Warnings

Warnings

Liver Warning: This product contains acataminophen. Severe liver damage may occure if you take.

  • more than 6 caplets in 24 hours, whihc is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • 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.

      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, beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Otc - Do Not Use

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Otc - Stop Use

Stop use and ask a doctor if

  • any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts for more than 3 days
  • These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding,

ask a health professional before use.

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

Directions

  • do not use more than directed
  • adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this box for important information.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, FD&C Blue#2, FD&C Yellow#6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Tension Headache Relief

• Acetaminophen & Caffeine

Pain Reliever/ Pain reliever aid

Actual Size

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