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#
Contacts and useful links#
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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70797-307-01 | 2024-01-30 | C162847 | 48780-1 | 0191ceaa-6415-198a-e063-dbdaa90aec3e | 9f047b67-9435-7914-e053-2995a90a0b41 |
| 70797-307-01 | 2023-11-09 | C162847 | 48780-1 | 0191ceaa-6415-198a-e063-dbdaa90aec3e | 9f047b67-9435-7914-e053-2995a90a0b41 |
| 70797-307-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6415-198a-e063-dbdaa90aec3e | 9f047b67-9435-7914-e053-2995a90a0b41 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70797-240-15 | Dr. Talbots Oral Comfort Pack | 15 g in 1 TUBE | GEL | 2 g | 30 [hp_X] in 15g | 2 |
| 70797-307-01 | Dr. Talbots Oral Comfort Pack | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 2 | |
| 70797-315-01 | Dr. Talbots Oral Comfort Pack | 1 in 1 BOTTLE | LIQUID | 6 [hp_X] in 118mL | 2 | |
| 70797-315-04 | Dr. Talbots Oral Comfort Pack | 118 mL in 1 BOTTLE | LIQUID | 2 mL in 2 | 6 [hp_X] in 118mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70797-240 | DR. TALBOTS ORAL COMFORT PACK (PAIN FEVER RELIEF AND SOOTHING GEL) KIT [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.] | 2 | Legacy NDC | 20211006_9f047b67-9435-7914-e053-2995a90a0b41.zip |
| 70797-307 | DR. TALBOTS ORAL COMFORT PACK (PAIN FEVER RELIEF AND SOOTHING GEL) KIT [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.] | 2 | Legacy NDC, 4 package rows | 20211006_9f047b67-9435-7914-e053-2995a90a0b41.zip |
| 70797-315 | DR. TALBOTS ORAL COMFORT PACK (PAIN FEVER RELIEF AND SOOTHING GEL) KIT [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.] | 2 | Current NDC, Legacy NDC | 20211006_9f047b67-9435-7914-e053-2995a90a0b41.zip |
Products#
Every source-derived product name is available through these pages.
- Dr. Talbots Oral Comfort Pack
- Pain Fever Relief and Soothing Gel
- Nuby Soothing Gel
- Soothing Gel
- ARNICA MONTANA ROOT
- TRIBASIC CALCIUM PHOSPHATE
- CALCIUM CATION
- WATER
- POTASSIUM SORBATE
- SODIUM BENZOATE
- MATRICARIA RECUTITA
- SORBIC ACID
- XANTHAN GUM
- GLYCERIN
- Dr. Talbots Pain Fever Relief
- Calendula officinalis, Chamomilla, Echinacea angustifolia, Eupatorium perfoliatum, Hepar sulphuris calcareum, Sulphur, Ferrum phosphoricum, Kali muriaticum
- EUPATORIUM PERFOLIATUM FLOWERING TOP
- CITRIC ACID MONOHYDRATE
- FERROSOFERRIC PHOSPHATE
- CALCIUM SULFIDE
- ECHINACEA ANGUSTIFOLIA
- CALENDULA OFFICINALIS FLOWERING TOP
- MATRICARIA CHAMOMILLA
- COSMOS SULPHUREUS FLOWERING TOP
- POTASSIUM CHLORIDE
- POTASSIUM CATION
- CONCORD GRAPE JUICE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70797-307 | 70797-307-01 |
| 70797-240 | 70797-240-15 |
| 70797-315 | 70797-315-04, 70797-315-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr. Talbots Pain Fever Relief | CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, FERRUM PHOSPHORICUM, KALI MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC. | 91d50391-f6a7-febf-e053-2995a90a1b02 | 2021-10-05 | Warnings | 70797-315-04 70797-315-01 70797-315 70797031504 70797031501 |
| cda1019b-487a-79c2-e053-2995a90af7f8 | 9f047b67-9435-7914-e053-2995a90a0b41 | 2021-10-05 | Warnings | cda1019b-487a-79c2-e053-2995a90af7f8 9f047b67-9435-7914-e053-2995a90a0b41 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
