Label: DR TALBOTS INFANT PAIN INFLAMTION RELIEF- arnica 12x,bellis perennis 12x,calendula officinalis 12x,chamomilla 12x,coffea cruda 12x,hypericum 12x,millefolium 12x,ferrum phosphoricum 12x,kali muriaticum 6x,magnesia phosphorica 6x liquid
- NDC Code(s): 70797-321-01
- Packager: Talbot’s Pharmaceuticals Family Products, LLC.
- 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 September 12, 2022
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- ACTIVE INGREDIENTS
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Dosage
Children under 6 months of age, consult a medical professional before using this product.
For sudden onset of symptoms: Use every 15 minutes for upto 8 doses until symtoms relieved, every 2 hours thereafter.
Children Dose
6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*
19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*
30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*
*Reduce frequency when symptoms improve. - Warning
- Keep Out Of Reach Of Children
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INGREDIENTS AND APPEARANCE
DR TALBOTS INFANT PAIN INFLAMTION RELIEF
arnica 12x,bellis perennis 12x,calendula officinalis 12x,chamomilla 12x,coffea cruda 12x,hypericum 12x,millefolium 12x,ferrum phosphoricum 12x,kali muriaticum 6x,magnesia phosphorica 6x liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70797-321 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 12 [hp_X] in 118 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 118 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 12 [hp_X] in 118 mL BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 12 [hp_X] in 118 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 6 [hp_X] in 118 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] in 118 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 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 ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 12 [hp_X] in 118 mL Inactive Ingredients Ingredient Name Strength CONCORD GRAPE JUICE (UNII: F7039Q79LP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70797-321-01 1 in 1 CARTON 09/12/2022 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/12/2022 Labeler - Talbot’s Pharmaceuticals Family Products, LLC. (078855555)