Headache Man - DailyMed Details

Headache Man

SPL v1

SPL

SPL Set ID 0eb58a42-0e4c-40f9-adef-ee96a113a2cd

Route

ORAL

Published

Effective Date 2020-12-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Anhydrous Citric Acid Alcohol Gellan Gum (low Acyl) Hydroxypropyl Betadex Propylene Glycol Sodium Benzoate Sucrose Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-12-31

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

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

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

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.

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.

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

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.

Active Ingredient

Acetaminophen 650mg

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

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.

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

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.

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)

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

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

Do Not Use (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.

Allergy Alert (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.

Liver Warning (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

Overdose Warning (Overdose warning)

Active Ingredient

Acetaminophen 650mg

Other Information (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

Sore Throat Warning (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.

Inactive Ingredients (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? (Questions or comments?)

Call 1-833-966-6673

Stop Use and Ask A Doctor If (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.

Principal Display Panel 50 Ml Bottle Label (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)

Advanced Ingredient Data

[{"name": "Acetaminophen", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "50", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Gellan Gum (Low Acyl)", "unii": "7593U09I4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydroxypropyl Betadex", "unii": "1I96OHX6EK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sucrose", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if you have liver disease", "53414-9": "If pregnant or breast feeding, ask a healthcare professional before use.", "Purpose": "Pain reliever/fever reducer", "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", "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.", "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.", "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", "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.", "Active Ingredient": "Acetaminophen 650mg", "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", "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.", "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", "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.", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:13.211545 · Updated: 2026-03-14T22:59:07.764303