Tension Headache Relief
FDA Label NDC 71309-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safrel Pharmaceuticals, Llc. for the product Tension Headache Relief (NDC 71309-105). 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 drug facts, purpose, active ingredients (in each caplet), uses, warnings, do not use, ask a doctor before use, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Tension Headache Relief

Purpose

Pain reliever, Pain reliever aid

Active Ingredients (In Each Caplet)

Acetaminophen   500mg

Caffeine   65mg

Uses

Temporarily relief minor aches and pains due to:

  • Headache
  • Muscular aches

Warnings

Liver warning: This product contains acetaminophen. severe liver damage may occur if you take:

  • more than 6 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

    • 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

  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask A Doctor Before Use

  • if you have liver disease

Ask A Doctor Or Pharmacist

If you are taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • Any new symptoms appear
  • Symptoms do not get better or worsen
  • Painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdosage, get medical help or contact a Poison Control Center (1-800-222-1222) 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 exceed recommended dosage.
  • Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours
  • Children under 12 years: Ask a doctor

Other Information

  • Store at controlled room temperature 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP 

Inactive Ingredients

  • Colloidal silicon doixide
  • Croscarmellose sodium
  • D&C red # 27
  • FD&C blue # 1
  • FD&C yellow # 6
  • Magnesium stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Pregelatinized starch
  • Polyvinyl pyrolidone
  • Stearic acid
  • Talc
  • Titanium dioxide

Questions Or Comments?

Call toll free 1-844-384-3723 Monday through Friday 9AM - 5PM EST or www.safrel.com

Tension Headache Relief Acetaminophen 500Mg Caffeine 65Mg Compare To Excedrin® Tension Headache Active Ingredients Distributed By: Safrel Pharmaceuticals, Llc Bridgewater, Nj 08807 Www.Safrle.Com

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