FDA.reportPublic FDA data

FLEXMORE

Manufacturer
Hyland's | Hyland's Inc.
Effective date
2022-10-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:50:55

Label at a glance#

ProductFLEXMORE
Active ingredientATROPA BELLADONNA, BRYONIA ALBA ROOT, COLCHICUM AUTUMNALE BULB, GUAIACUM OFFICINALE RESIN, KALMIA LATIFOLIA LEAF, RHODODENDRON TOMENTOSUM LEAFY TWIG, TRIBASIC CALCIUM PHOSPHATE, COMFREY ROOT, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP
Label structure9 sections

Indications and uses

■ Help 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

Dosage and administration

■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2-3 tablets under tongue every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Joint Pain

Stiff & Swollen Joints

Rheumatic Pain

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose

Belladonna 30X HPUS

(less than 0.000000000001% Alkaloids, calculated)

minor arthritic pain, muscular cramping
Bryonia Alba 30X HPUSaching in muscles, worse from motion
Calcarea Phosphorica 6X HPUSstiffness, neck and back pain
Colchicum Autumnale 12X HPUSminor rheumatic pain
Guaiacum 12X HPUSminor arthritic pain, stiffness and mobility
Kalmia Latifolia 12X HPUSminor rheumatic pain
Ledum Palustre 30X HPUSminor swelling, joint pain
Rhus Toxicodendron 30X HPUSstiffness, neck and back pain
Ruta Graveolens 12X HPUSjoint pain, minor rheumatic pain
Symphytum Officinale 30X HPUSjoint pain

HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Help 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

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ pain gets worse or lasts more than 7 days.
■ new symptoms occur.

■ redness or swelling is present.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

Adults and children

12 years and over

At onset of symptoms, dissolve 2-3 tablets
under tongue every 4 hours until relieved.

Children under

12 years of age

Ask a doctor before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose

Indications and Usage

RECENT MAJOR CHANGES SECTION

Added square bullets

Updated to:

■ Help temporarily relieve symptoms of minor arthritis pain, including:
■ minor swelling or stiffness joint, neck or back pain
■ muscular cramping associated with minor rheumatic pain

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

FLEXMORE®

ARTHRITIS PAIN RELIEF*

  • Joint Pain
  • Stiff & Swollen Joints
  • Rheumatic Pain

50

QUICK-DISSOLVING

TABLETS

HOMEOPATHIC

cartoncarton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-339754973-3397-1, 54973-3397-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
KALMIA LATIFOLIA LEAF79N6542N18ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
COMFREY ROOTM9VVZ08EKQACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2c40113e-3bb4-3d8e-e063-6394a90a435f8a365f39-5afa-af8d-e053-2995a90a5fd52025-01-21WarningsExact identifier
spl set id: 8a365f39-5afa-af8d-e053-2995a90a5fd5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.