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

Headache Man by

Drug Labeling and Warnings

Headache Man by is a Otc medication manufactured, distributed, or labeled by No More Pills, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73173-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	650 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73173-010-50	50 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	12/31/2020
2	NDC: 73173-010-51	50 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/31/2020

Labeler - No More Pills, LLC (111493085)