Label: DR TALBOTS INFANT TUMMY ACHE RELIEF- calendula officinalis 12x,carbo vegetabilis 12x,lycopodium 30x,foeniculum vulgare 12x,nux moschata 12x,zingiber officinale 12x,kali muriaticum 6x,magnesia phosphorica 12x,natrum phosphoricum 6x liquid
- NDC Code(s): 70797-317-01
- 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 28, 2022
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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 up to 8 doses until symptoms 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.
- Questions
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Instruction
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,
every 2 hours thereafterChildren 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
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INGREDIENTS AND APPEARANCE
DR TALBOTS INFANT TUMMY ACHE RELIEF
calendula officinalis 12x,carbo vegetabilis 12x,lycopodium 30x,foeniculum vulgare 12x,nux moschata 12x,zingiber officinale 12x,kali muriaticum 6x,magnesia phosphorica 12x,natrum phosphoricum 6x liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70797-317 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 6 [hp_X] in 118 mL NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 12 [hp_X] in 118 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_X] in 118 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 118 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 12 [hp_X] in 118 mL FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6) FENNEL SEED 12 [hp_X] in 118 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [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 MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 12 [hp_X] in 118 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X] in 118 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) APPLE JUICE (UNII: 9871T0PD5P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70797-317-01 1 in 1 CARTON 09/28/2022 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 09/28/2022 Labeler - Talbot's Pharmaceuticals Family Products,LLC. (078855555)