Label: DR. TALBOTS ORAL COMFORT PACK- pain fever relief and soothing gel kit
- NDC Code(s): 71240-240-15, 71240-307-01, 71240-315-01, 71240-315-04
- Packager: Ningbo Longwell Baby Products Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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 = kilogramsChildren 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
- QUESTIONS
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR. TALBOTS ORAL COMFORT PACK
pain fever relief and soothing gel kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71240-307 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71240-307-01 1 in 1 PACKAGE, COMBINATION; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 07/06/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 TUBE 2 g Part 2 0 BOTTLE 2 mL in 2 Part 1 of 2 NUBY SOOTHING GEL
soothing gel gelProduct Information Item Code (Source) NDC:71240-240 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 30 [hp_X] in 15 g TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 15 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 12 [hp_X] in 15 g Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SORBIC ACID (UNII: X045WJ989B) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71240-240-15 15 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/06/2020 Part 2 of 2 DR. TALBOTS PAIN FEVER RELIEF
calendula officinalis, chamomilla, echinacea angustifolia, eupatorium perfoliatum, hepar sulphuris calcareum, sulphur, ferrum phosphoricum, kali muriaticum liquidProduct Information Item Code (Source) NDC:71240-315 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COSMOS SULPHUREUS FLOWERING TOP (UNII: WKB165X336) (COSMOS SULPHUREUS FLOWERING TOP - UNII:WKB165X336) COSMOS SULPHUREUS FLOWERING TOP 12 [hp_X] in 118 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 118 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 118 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 118 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 12 [hp_X] in 118 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 6 [hp_X] in 118 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 12 [hp_X] in 118 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 12 [hp_X] in 118 mL Inactive Ingredients Ingredient Name Strength CONCORD GRAPE JUICE (UNII: F7039Q79LP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71240-315-01 1 in 1 CONTAINER 1 NDC:71240-315-04 118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/06/2020 Labeler - Ningbo Longwell Baby Products Co.,Ltd. (527868252)