FDA Label for Dr. Talbots Oral Comfort Pack
View Indications, Usage & Precautions
Dr. Talbots Oral Comfort Pack Product Label
The following document was submitted to the FDA by the labeler of this product Ningbo Longwell Baby Products Co.,ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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.
Otc - Purpose
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
Indications & Usage
Temporarily relieves
- irritability
- cold chills
- flu-like symptoms
- fever
- body ache
- general soreness
- swollen glands
Warnings
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
If pregnant or breastfeeding, consult your doctor before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & 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 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
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.
Otc - Questions
Questions or Comments?
Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST
Other Safety Information
Other Information
Tamper evident - Do not use if tube tip is cut prior to opening.
Package Label.Principal Display Panel
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