Tension Headache Relief Tablet, Film Coated
FDA Label NDC 83586-118

16 label sections · Submitted to the FDA by Hhh Pharmaceuticals · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hhh Pharmaceuticals for the product Tension Headache Relief (NDC 83586-118). 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 ingredients (in each caplet), purposes, uses, liver warning, caffeine warning, do not use, ask a doctor before use if, 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

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

Uses

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

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 occur
  • symptoms do not get better or worsen
  • painful area is red or swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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 (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 room temperature 15-30°C (59-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, D&C blue #2, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinyl alcohol, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.

Questions Or Comments?

Call 1-844-832-1138

9AM - 5PM Monday - Friday

Other

Distributed by:

HHH Pharmaceuticals,

Wilmington, DE 19801


www.hhhpharma.com

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