NDC 73173-010 Headache Man No More Pills, One Shot, Headache Pain Relief

Acetaminophen

NDC Product Code 73173-010

NDC Product Information

Headache Man No More Pills, One Shot, Headache Pain Relief with NDC 73173-010 is a a human over the counter drug product labeled by No More Pills, Llc. The generic name of Headache Man No More Pills, One Shot, Headache Pain Relief is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: No More Pills, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Headache Man No More Pills, One Shot, Headache Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 650 mg/50mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: No More Pills, Llc
Labeler Code: 73173
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-31-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

Headache Man No More Pills, One Shot, Headache Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

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:headachesore throatminor pain of arthritismuscle achescold and flutoothachepremenstrual and menstrual crampstemporarily reduces fever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 6 bottles in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks daily, while using this product

Allergy Alert

  • Acetaminophen may cause severe skin reactions.Symptoms may includeskin reddeningblistersrashIf 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 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese 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 missingeach 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.

* Please review the disclaimer below.