FDA.reportPublic FDA data

Dr. Talbots Pain Inflammation Relief

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC.
Effective date
2021-10-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:03

Label at a glance#

ProductDr. Talbots Pain Inflammation Relief
Active ingredientARABICA COFFEE BEAN, MAGNESIUM PHOSPHATE, DIBASIC, ACHILLEA MILLEFOLIUM, ARNICA MONTANA, FERROSOFERRIC PHOSPHATE, HYPERICUM PERFORATUM, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA CHAMOMILLA, POTASSIUM CHLORIDE
Label structure10 sections

Indications and uses

Uses Temporarily relieves minor aches and pains due to: bruises toothache nerve pain vascular pain nerve pain inflammation and swelling from trauma muscle pain and swelling joint and bone pain

Dosage and administration

Shake before use, natural juice may settle Measure only with the dosing syringe provided Do not use dosing syringe with other products On dosing syringe, weight is specific to product On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms Children under 6 months of age, consult a medical professional before using this product. For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until sy...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Arnica 12X HPUS
Bellis perennis 12X HPUS
Calendula Officinalis 12X HPUS
Chamomilla 12X HPUS

Coffea cruda 12X HPUS
Hypericum 12X HPUS
Millefolium 12X HPUS
Cell Salts
Ferrum phosphoricum 12X HPUS
Kali muriaticum 6X HPUS

Magnesia phosphorica 6XHPUS

Active ingredientsActive ingredients

Uses

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and pains due to:

  • bruises
  • toothache
  • nerve pain
  • vascular pain
  • nerve pain
  • inflammation and swelling from trauma
  • muscle pain and swelling
  • joint and bone pain

IndicationIndication

Warnings

WARNINGS SECTION

Stop use and ask doctor if:

  • fever develops, worsens, or lasts more than 3 days
  • pain gets worse or lasts more than 7 days
  • other symptoms persist for more than 7 days or worsen
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
  • Please consult your physician immediately for a worsening condition.

WarningWarning

Pregnancy or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, consult your doctor before use.

PregnancyPregnancy

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

07-20-202007-20-2020

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

DosageDosage

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Questions

OTC - QUESTIONS SECTION

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Purpose

OTC - PURPOSE SECTION

Purpose
Trauma, bruises
Injuries to muscles

Reduces inflammation
Hypersensitivity

Sensitiveness to pain
Injuries to nerves, nerve pain
Vascular injuries
Inflammation due to trauma
Swelling

Spasmodic pains

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-316-01Dr. Talbots Pain Inflammation Relief1 in 1 CARTONLIQUID13
70797-316-04Dr. Talbots Pain Inflammation Relief118 mL in 1 BOTTLELIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-316DR. TALBOTS PAIN INFLAMMATION RELIEF (ARNICA, BELLIS PERENNIS, CALENDULA OFFICINALIS, CHAMOMILLA, COFFEA CRUDA, HYPERICUM, MILLEFOLIUM, FERRUM PHOSPHORICUM, KALI MURIATICUM, MAGNESIA PHOSPHORICA) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]3Current NDC, Legacy NDC, 2 package rows20211006_91d57aae-7c68-cc4a-e053-2995a90aad9d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70797-31670797-316-04, 70797-316-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARABICA COFFEE BEAN3SW678MX72ACTIB
MAGNESIUM PHOSPHATE, DIBASICA1Y870209ZACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
ARNICA MONTANAO80TY208ZWACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
CONCORD GRAPE JUICEF7039Q79LPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BELLIS PERENNIS2HU33I03UYACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
WATER059QF0KO0RIACT
POTASSIUM CHLORIDE660YQ98I10ACTIB

Source Document#

Source XML

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
Dr. Talbots Pain Inflammation ReliefARNICA, BELLIS PERENNIS, CALENDULA OFFICINALIS, CHAMOMILLA, COFFEA CRUDA, HYPERICUM, MILLEFOLIUM, FERRUM PHOSPHORICUM, KALI MURIATICUM, MAGNESIA PHOSPHORICATalbot's Pharmaceuticals Family Products, LLC.91d57aae-7c68-cc4a-e053-2995a90aad9d2021-10-05WarningsExact identifier
ndc (package): 70797-316-01
ndc (package): 70797-316-04
ndc (product): 70797-316
ndc11 (package): 70797031601
ndc11 (package): 70797031604
spl id: cda1180e-7f69-69b2-e053-2995a90a5015
spl set id: 91d57aae-7c68-cc4a-e053-2995a90aad9d

Reported adverse events (FAERS/openFDA)#

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