Label: COMPLETE ALLERGY 4 KIDS- aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed liquid
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- NDC Code(s): 54973-3097-1, 54973-3097-2
- 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 June 8, 2020
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active Ingredients Purpose Aconitum Napellus 6X HPUS itchy throat, sneezing Allium Cepa 6X HPUS hay fever, runny nose, watery, itchy eyes Euphrasia 6X HPUS nasal inflammation, nasal discharge Galphimia Glauca 12X HPUS sneezing, runny nose Histaminum Hydrochloricum 12X HPUS ear pain Luffa Operculata 12X HPUS sinus pain, headache Natrum Muriaticum 6X HPUS ear pain, itchy, burning eyes Nux Vomica 6X HPUS
(0.0000016% Alkaloids, calculated)itchy nose Pulsatilla 6X HPUS sinus pressure Sabadilla 6X HPUS hay fever, uncontrollable sneezing “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
- Warnings
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Drug Facts (continued)
Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, tsp = teaspoon
Children ages 2-under 6 years: 5 mL or 1 teaspoon up to 6 times per day (every 4 hours).
Children 6 to under 12 years: 10 mL or 2 teaspoons up to 6 times per day (every 4 hours).
Adults and children 12 years and over: 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)
- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
COMPLETE ALLERGY 4 KIDS
aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3097 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [hp_X] in 1 mL LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X] in 1 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] in 1 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3097-1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 2 NDC:54973-3097-2 19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2010 Labeler - Hyland's, Inc. (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3097) Establishment Name Address ID/FEI Business Operations Lifetech Resources 081239587 manufacture(54973-3097) , pack(54973-3097)
