CHILDRENS ALPHA COLD FLU- aconitum napellus, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus tablet

CHILDRENS ALPHA COLD FLU by

Drug Labeling and Warnings

CHILDRENS ALPHA COLD FLU by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Aconitum napellus 7X

Bryonia 7X

Eupatorium perfoliatum 7X

Gelsemium sempervirens 7X

Ipecacuanha 6X

Phosphorus 12X

INACTIVE INGREDIENT

INACTIVE INGREDIENT:

Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose

PURPOSE

PURPOSE:

Temporarily relieves these symptoms due to colds and flu:  fever, chills, body aches and pains, runny nose, stuffy nose, headache, coughing, minor sore throat pain.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

INDICATIONS & USAGE

INDICATIONS AND USAGE:

Temporarily relieves these symptoms due to colds and flu: fever, chills, body aches and pains, runny nose, stuffy nose, headache, coughing, minor sore throat pain.

WARNINGS

WARNINGS:

Sore Throat Warning:

Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serious. 

Consult a physician promptly.

ASK DOCTOR

Ask a doctor before useif you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is accomapnied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

'These could be signs of a serious condition.

DOSAGE & ADMINISTRATION

DOSAGE:

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS ALPHA COLD FLU 
aconitum napellus, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus tablet

Product 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
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

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-9098)