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Dr. talbots oral comfort pack - Prescription Drug Labeling

Product NDC Code 70797-307
Drug Name

Dr. talbots oral comfort pack

Type Brand
Route ORAL, TOPICAL
Dosage Form KIT
Labeler Name Talbot's Pharmaceuticals Family Products, LLC.
Packages
Package NDC Code Description
70797-307-01 1 kit in 1 package, combination (70797-307-01) * 15 g in 1 tube (70797-240-15) * 1 bottle in 1 bottle (70797-315-01) > 118 ml in 1 bottle (70797-315-04)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
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 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.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Citric acid, glycerin, grape juice, potassium sorbate, purified water Inactive ingredients Aqua (Purified Water), Potassium Sorbate NF, Sodium Benzoate NF, Sorbic Acid NF, Vegetable Glycerin USP, Xanthan Gum NF.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Temporarily relieves irritability cold chills flu-like symptoms fever body ache general soreness swollen glands

Purpose

Information about the drug product’s indications for use.
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 Purpose† sore gums sensitive gums pain associated with irritability

Spl product data elements

Usually a list of ingredients in a drug product.
Dr. Talbots Oral Comfort Pack Pain Fever Relief and Soothing Gel Nuby Soothing Gel Soothing Gel ARNICA MONTANA ROOT ARNICA MONTANA ROOT TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION WATER POTASSIUM SORBATE SODIUM BENZOATE MATRICARIA RECUTITA 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 EUPATORIUM PERFOLIATUM FLOWERING TOP GLYCERIN CITRIC ACID MONOHYDRATE FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE CALCIUM SULFIDE CALCIUM SULFIDE ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP MATRICARIA CHAMOMILLA MATRICARIA RECUTITA COSMOS SULPHUREUS FLOWERING TOP COSMOS SULPHUREUS FLOWERING TOP POTASSIUM CHLORIDE POTASSIUM CATION POTASSIUM SORBATE WATER CONCORD GRAPE JUICE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PDP

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose (or accidental ingestion), get medical help or contact a Poison Control Center right away. 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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Tamper evident - Do not use if tube tip is cut prior to opening.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding , consult your doctor before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API