NDC 54973-4005 Quitters Relief Headache

Aconitum Napellus, Atropa Belladonna, Delphinium Staphisagria Seed, Iris Versicolor Root And Strychnos Nux-vomica Seed

NDC Product Code 54973-4005

NDC CODE: 54973-4005

Proprietary Name: Quitters Relief Headache What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aconitum Napellus, Atropa Belladonna, Delphinium Staphisagria Seed, Iris Versicolor Root And Strychnos Nux-vomica Seed What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - OFF WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

  • 54973 - Hyland's

NDC 54973-4005-1

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET in 1 BOTTLE

NDC Product Information

Quitters Relief Headache with NDC 54973-4005 is a a human over the counter drug product labeled by Hyland's. The generic name of Quitters Relief Headache is aconitum napellus, atropa belladonna, delphinium staphisagria seed, iris versicolor root and strychnos nux-vomica seed. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Quitters Relief Headache 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.

  • IRIS VERSICOLOR ROOT 6 [hp_X]/1
  • DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1
  • ACONITUM NAPELLUS 6 [hp_X]/1
  • ATROPA BELLADONNA 6 [hp_X]/1

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 LACTOSE (UNII: 3SY5LH9PMK)
  • ACACIA (UNII: 5C5403N26O)

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: Hyland's
Labeler Code: 54973
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 12-15-2020 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.

Quitters Relief Headache Product Label Images

Quitters Relief Headache 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

Otc - Purpose

Temporarily relieves headaches associated with smoking cessation

Active Ingredients

Active ingredientsPurposeAconitum Napellus 6X HPUSheadacheBelladonna 6X HPUS (0.0000003% Alkaloids, calculated)headacheIris Versicolor 6X HPUSheadacheNux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)headacheStaphysagria 12X HPUSheadache

Other

"HPUS" indicates that the active ingredients are in the official HomeopathicPharmacopoeia of the United States.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Uses

■ Temporarily relieves headaches associated with smoking cessation

Otc - Pregnancy Or Breast Feeding

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Otc - Do Not Use

Do not use more than directed.

Otc - Ask Doctor

Consult a physician if symptoms persist for more than 7 days or worsen.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Overdosage

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

Adults ages 18years and overDissolve 2 tablets under tongue every 15 minutes up to 4 doses,then every 4 hours until relieved.

Other Information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive Ingredients

Acacia Gum, Lactose.

* Please review the disclaimer below.