Headache Man
FDA Label NDC 73173-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by No More Pills, Llc for the product Headache Man (NDC 73173-010). 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, active ingredient, purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Distributed by No More Pills, LLC

Active Ingredient

Acetaminophen 650mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • sore throat
  • minor pain of arthritis
  • muscle aches
  • cold and flu
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 bottles in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily, 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.

Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other drug containing acetaminophen (prescription or non- prescription). 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.

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center (800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults: take one Headache Man One Shot™ every 4 to 6 hours, or as directed by a doctor, while symptoms persist; do not take more than 6 Headache Man Shots™ in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)
  • do not use if neckband on bottle is broken or missing
  • each 50 mL bottle contains: sodium 8 mg

Inactive Ingredients

citric acid, ethyl alcohol (1.1%), gellan (low acyl), hydroxypropyl betadex, lemon flavor (organic), natural flavors, propylene glycol, sodium benzoate, sucrose, water.

Questions Or Comments?

Call 1-833-966-6673

Principal Display Panel - 50 Ml Bottle Label

NEW

HEADACHE MAN
NO MORE PILLS!™

ONE SHOT™

Liquid Headache-Pain relief
650mg Acetaminophen
Pain Reliever/Fever Reducer
Compare to
Tylenol®
Active Ingredient

  • Works in Minutes
  • Great Tasting
  • Patented
  • Contains Alcohol 1.1%

    • ORGANIC
    LEMON FLAVOR

    1.7 fl oz (50 mL)

    Principal Display Panel (50 mL Bottle Label)

    Principal Display Panel (50 mL Bottle Label)

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