Label: CHILDRENS ALPHA COLD FLU- aconitum napellus, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus tablet
- NDC Code(s): 53499-9098-2
- Packager: Schwabe North America, 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 March 21, 2022
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- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTs
- Purpose
- Indications & Usage
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Dosage & Administration
Tablets may be chewed or placed on the child's tongue and allowed to dissolve or crushed in water in a teaspoon.
Children 6 to 12 years of age: At the first sign of cold or flu, take 3 tablets every hour; as symptoms improve 3 tablets every 3 hours, then 3 times a day until well.
Children under 2 to 5 years of age: 2 tablets as above.
Children under 2 years of age: Consult a doctor. - Warnings
- Ask Doctor
- Stop use
- Pregnancy or Breast Feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS ALPHA COLD FLU
aconitum napellus, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9098 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 7 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 7 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 7 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 7 [hp_X] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 6 [hp_X] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white (B;T) Score no score Shape ROUND (BT) Size 8mm Flavor Imprint Code B;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-9098-2 1 in 1 BOX 07/01/2017 01/31/2025 1 100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2017 01/31/2025 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe Mexico, S.A. de C.V. 812805901 manufacture(53499-9098)