Label: 4 KIDS PAIN RELIEF- anemone pulsatilla, toxicodendron pubescens leaf, gelsemium sempervirens root, phosphorus, eupatorium perfoliatum flowering top, bryonia alba root, arnica montana and aconitum napellus liquid
- NDC Code(s): 54973-4015-1
- Packager: Hyland's Inc.
- 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 January 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Drug Facts
Active ingredients
Aconitum Napellus 30X HPUS
Arnica Montana 30X HPUS
Bryonia Alba 30X HPUS
Eupatorium Perfoliatum 30X HPUS
Gelsemium Sempervirens 12X HPUS
Phosphorus 12X HPUS
Pulsatilla 9X HPUS
Rhus Toxicodendron 12X HPUS
"HPUS" indicates that the active ingredients are in the
official Homeopathic Pharmacopoeia of the United States.
- Uses
- Warnings
-
Directions
- Shake well before using.
- Measure only with the dosing cup provided.
- Do not use dosing cup with other products.
- On dosing cup, mL = milliliter.
Children 2 years
to under 6 years
5 mL every 15 minutes for
4 doses, then every 4 hours until relieved.
Children 6 years
to under 12 years
10 mL every 15 minutes for
4 doses, then every 4 hours until relieved.
Adults and children
12 years and over
15 mL every 15 minutes for
4 doses, then every 4 hours until relieved.
- Drug Facts (continued)
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
4 KIDS PAIN RELIEF
anemone pulsatilla, toxicodendron pubescens leaf, gelsemium sempervirens root, phosphorus, eupatorium perfoliatum flowering top, bryonia alba root, arnica montana and aconitum napellus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-4015 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 30 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 12 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 9 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-4015-1 1 in 1 CARTON 01/27/2020 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/27/2020 Labeler - Hyland's Inc. (008316655)