NDC 54973-3397 Flexmore

Atropa Belladonna, Bryonia Alba Root, Colchicum Autumnale Bulb, Guaiacum Officinale Resin, Kalmia Latifolia Leaf, Rhododendron Tomentosum Leafy Twig, Ruta Graveolens Flowering Top, Tribasic Calcium Phosphate, Comfrey Root And Toxicodendron Pubescens Leaf

NDC Product Code 54973-3397

NDC Code: 54973-3397

Proprietary Name: Flexmore 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: Atropa Belladonna, Bryonia Alba Root, Colchicum Autumnale Bulb, Guaiacum Officinale Resin, Kalmia Latifolia Leaf, Rhododendron Tomentosum Leafy Twig, Ruta Graveolens Flowering Top, Tribasic Calcium Phosphate, Comfrey Root And Toxicodendron Pubescens Leaf 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)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

NDC 54973-3397-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 50 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Flexmore with NDC 54973-3397 is a a human over the counter drug product labeled by Hyland's. The generic name of Flexmore is atropa belladonna, bryonia alba root, colchicum autumnale bulb, guaiacum officinale resin, kalmia latifolia leaf, rhododendron tomentosum leafy twig, ruta graveolens flowering top, tribasic calcium phosphate, comfrey root and toxicodendron pubescens leaf. 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.

Flexmore 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.

  • ATROPA BELLADONNA 30 [hp_X]/1
  • BRYONIA ALBA ROOT 30 [hp_X]/1
  • COLCHICUM AUTUMNALE BULB 12 [hp_X]/1
  • GUAIACUM OFFICINALE RESIN 12 [hp_X]/1
  • KALMIA LATIFOLIA LEAF 12 [hp_X]/1
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 30 [hp_X]/1
  • TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/1
  • COMFREY ROOT 30 [hp_X]/1
  • TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/1
  • RUTA GRAVEOLENS FLOWERING TOP 12 [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: 06-01-2019 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: 12-31-2020 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.

Flexmore Product Label Images

Flexmore 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

Active Ingredients

Belladonna 30X HPUS(less than 0.000000000001% Alkaloids, calculated)Bryonia 30X HPUSCalcarea Phosphorica 6X HPUSColchicum Autumnale 12X HPUSGuaiacum 12X HPUSKalmia Latifolia 12X HPUSLedum Palustre 30X HPUSRhus Toxicodendron 30X HPUSRuta Graveolens 12X HPUSSymphytum Officinale 30X HPUS"HPUS" indicates that the active ingredients are in the official HomeopathicPharmacopoeia of the United States.

Uses

  • Temporarily relieves the symptoms of minor arthritis pain, including:minor swelling or stiffness joint, neck or back pain muscular cramping associated with minor rheumatic pain

Warnings

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

Other

Do not use more than directed.

  • Consult a physician if: 
  • Symptoms persist for more than 7 days or worsen.irritation, pain or redness persists or worsens.

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.

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

Otc - Keep Out Of Reach Of Children

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

Directions

Adults and children12 years and overDissolve 2-3 tablets under tongueevery 4 hours until relieved.Children under 12 yearsConsult a physician.

Other Information

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing. The inner packaged bottle is child-resistant.

Inactive Ingredients

Acacia Gum, Lactose

Otc - Purpose

ArthritisMinor Rheumatic PainStiffness & CrampingSwelling of Joints

* Please review the disclaimer below.