FDA Label for Headache Man No More Pills, One Shot, Headache Pain Relief

View Indications, Usage & Precautions

Headache Man No More Pills, One Shot, Headache Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product No More Pills, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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

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