Dr. Talbots Oral Comfort Pack

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC.
Effective date
2021-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:15:03

Label at a glance#

ProductDr. Talbots Oral Comfort Pack
Active ingredientARNICA MONTANA ROOT, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, ECHINACEA ANGUSTIFOLIA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA CHAMOMILLA, COSMOS SULPHUREUS FLOWERING TOP, POTASSIUM CHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Calendula officinalis 12X HPUS

Chamomilla 12X HPUS

Echinacea angustifolia 12X HPUS

Eupatorium perfoliatum 12X HPUS

Hepar sulphuris calcareum 12X HPUS

Sulphur 12X HPUS

Cell Salts

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

OTC - PURPOSE SECTION

Purpose

Reduces inflammation

Hypersensitivity, irritability

Weakness, aching body

Aching pain, flu-like symptoms

Hypersensitive to cold, chills

Headache, symptoms of fever

Symptoms of fever

Glandular swellings, inflammation

INDICATIONS & USAGE SECTION

Temporarily relieves

  • irritability
  • cold chills
  • flu-like symptoms
  • fever
  • body ache
  • general soreness
  • swollen glands

WARNINGS SECTION

Stop use and ask doctor if:

fever wosens or lasts more than 2 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, consult your doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose (or accidental ingestion), get medical help or contact a Poison Control Center right away.

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or Comments?

Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Arnica Montana, radix 30X HPUS 3.33%

Calcarea Phosphorica 12X HPUS 3.33%

Chamomilla 12X HPUS 3.33%

The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose†

sore gums

sensitive gums

pain associated with irritability

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose contact a medical professional or a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

• Wash hands before use.

• Cut open tip of tube on score mark.

• Use your fingertip or cotton applicator to gently apply a small pea-size amount of Dr. Talbot's Soothing Gel to the affected area every 15 minutes as necessary or as directed by a physician or healthcare provider.

OTHER SAFETY INFORMATION

Other Information

Tamper evident - Do not use if tube tip is cut prior to opening.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aqua (Purified Water), Potassium Sorbate NF, Sodium Benzoate NF, Sorbic Acid NF, Vegetable Glycerin USP, Xanthan Gum NF.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-240-15Dr. Talbots Oral Comfort Pack15 g in 1 TUBEGEL2 g30 [hp_X] in 15g2
70797-307-01Dr. Talbots Oral Comfort Pack1 in 1 PACKAGE, COMBINATIONKIT12
70797-315-01Dr. Talbots Oral Comfort Pack1 in 1 BOTTLELIQUID6 [hp_X] in 118mL2
70797-315-04Dr. Talbots Oral Comfort Pack118 mL in 1 BOTTLELIQUID2 mL in 26 [hp_X] in 118mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-240DR. TALBOTS ORAL COMFORT PACK (PAIN FEVER RELIEF AND SOOTHING GEL) KIT [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]2Legacy NDC20211006_9f047b67-9435-7914-e053-2995a90a0b41.zip
70797-307DR. TALBOTS ORAL COMFORT PACK (PAIN FEVER RELIEF AND SOOTHING GEL) KIT [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]2Legacy NDC, 4 package rows20211006_9f047b67-9435-7914-e053-2995a90a0b41.zip
70797-315DR. TALBOTS ORAL COMFORT PACK (PAIN FEVER RELIEF AND SOOTHING GEL) KIT [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]2Current NDC, Legacy NDC20211006_9f047b67-9435-7914-e053-2995a90a0b41.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70797-30770797-307-01
70797-24070797-240-15
70797-31570797-315-04, 70797-315-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Talbots Pain Fever ReliefCALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, FERRUM PHOSPHORICUM, KALI MURIATICUMTalbot's Pharmaceuticals Family Products, LLC.91d50391-f6a7-febf-e053-2995a90a1b022021-10-05WarningsExact identifier
ndc (package): 70797-315-04
ndc (package): 70797-315-01
ndc (product): 70797-315
ndc11 (package): 70797031504
ndc11 (package): 70797031501
cda1019b-487a-79c2-e053-2995a90af7f89f047b67-9435-7914-e053-2995a90a0b412021-10-05WarningsExact identifier
spl id: cda1019b-487a-79c2-e053-2995a90af7f8
spl set id: 9f047b67-9435-7914-e053-2995a90a0b41

Reported adverse events (FAERS/openFDA)#

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