Label: HEADACHE MAN NO MORE PILLS, ONE SHOT, HEADACHE PAIN RELIEF- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
  • Warnings

    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.

    Ask a doctor before use if you have liver disease

    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.

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

    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

  • SPL UNCLASSIFIED SECTION

    Distributed by No More Pills, LLC

  • 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
  • INGREDIENTS AND APPEARANCE
    HEADACHE MAN   NO MORE PILLS, ONE SHOT, HEADACHE PAIN RELIEF
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73173-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    Gellan Gum (Low Acyl) (UNII: 7593U09I4D)  
    Hydroxypropyl Betadex (UNII: 1I96OHX6EK)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sucrose (UNII: C151H8M554)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73173-010-5050 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/31/2020
    2NDC:73173-010-5150 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/31/2020
    Labeler - No More Pills, LLC (111493085)
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