Label: 4 KIDS LEG PAIN RELIEF- tribasic calcium phosphate, arnica montana, oyster shell calcium carbonate, crude, copper, eupatorium perfoliatum flowering top, magnesium phosphate, dibasic trihydrate, phosphorus, guaiacum officinale resin and phosphoric acid tablet
- NDC Code(s): 54973-3383-1, 54973-3383-2
- 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 November 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredients
Arnica Montana 30X HPUS
Calcarea Carbonica 12X HPUS
Calcarea Phosphorica 12X HPUS
Cuprum Metallicum 12X HPUS
Eupatorium Perfoliatum 30X HPUS
Guaiacum 12X HPUS
Magnesia Phosphorica 12X HPUS
Phosphoricum Acidum 12X HPUS
Phosphorus 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic
Pharmacopœia of the United States.
Purpose
Arnica Montana 30X HPUS ..............................muscle soreness, stiffness and pain
Calcarea Carbonica 12X HPUS............................................cramps and pain in legs
Calcarea Phosphorica 12X HPUS................. aching pain in limbs, cramps in calves
Cuprum Metallicum 12X HPUS........................pain in legs and calves when resting
Eupatorium Perfoliatum 30X HPUS ................... soreness of limbs, aching in limbs
Guaiacum 12X HPUS ..............................................................muscle and joint pain
Magnesia Phosphorica 12X HPUS ...................................pain and cramps in calves
Phosphoricum Acidum 12X HPUS....pain in thighs, cramps in thighs, legs and feet
Phosphorus 12X HPUS...............................cramps in legs, knees extending to feet
- Uses
- Warnings
-
Directions
Children 2 years
to under 6 years
Dissolve 2 tablets under tongue every 15 minutes for up
to 4 doses until relieved, then every 6 hours as required.
Children 6 years
to under 12 years
Dissolve 3 tablets under tongue every 15 minutes for up
to 4 doses until relieved, then every 6 hours as required.
Adults and children
12 years and over
Dissolve 4 tablets under tongue every 15 minutes, for up
to 4 doses until relieved, then every 6 hours as required.
- Inactive ingredients
- Questions or comments?
- Principal Display Panel - 50 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
4 KIDS LEG PAIN RELIEF
tribasic calcium phosphate, arnica montana, oyster shell calcium carbonate, crude, copper, eupatorium perfoliatum flowering top, magnesium phosphate, dibasic trihydrate, phosphorus, guaiacum officinale resin and phosphoric acid tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3383 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 12 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_X] GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN 12 [hp_X] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ACACIA (UNII: 5C5403N26O) Product Characteristics Color white (White to Off White) Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3383-1 1 in 1 CARTON 11/01/2018 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3383-2 6 in 1 PACKET; Type 0: Not a Combination Product 11/01/2018 12/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/01/2018 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3383) , pack(54973-3383) , label(54973-3383)