Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID a8bc1713-b6ee-4231-bcf8-bdf483c1c076
Route
ORAL
Published
Effective Date 2014-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Drosera Intermedia (30 [hp_X]) Spongia Officinalis Whole Carbonate Ion Phosphorus Pulsatilla Vulgaris Atropa Belladonna Ipecac
Inactive Ingredients
Isomalt Cochineal

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: green Color: orange Color: red Size: 31 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-30

Description

Non-Active Ingredients Non-active ingredients for kids cough apple: Isomalt, Natural Apple Flavour, Natural Colours, Carokram and Vegetable (Blue Gardinea) Non-active ingredients for kids cough orange: Isomalt, Natural Orange and Colour (Annato), Non-active ingredients for kids cough raspberry: Isomalt, Natural Raspberry Flavour and Natural Colour Carmine (Cochineal)


Medication Information

Warnings and Precautions

Warning:

Warning for kids cough apple:

If symptoms persist or suddenly worsen, consult your

healthcare specialist.

Warning for kids cough orange:

If symptoms persist or suddenly worsen, consult your

healthcare specialist.

Warning for kids cough raspberry:

If symptoms persist or suddenly worsen, consult your

healthcare specialist.

Indications and Usage

Indications for kids cough apple:

For natural, temporary relief of cough

and sore throat symptoms (hoarseness and

dry cough). If coughing persists,

consult a heathcare professional.

Indications for kids cough orange:

For natural, temporary relief of cough

and sore throat symptoms (hoarseness and

dry cough). If coughing persists,

consult a healthcare professional.

Indications for kids cough raspberry:

For natural, temporary relief of cough

and sore throat symptoms (hoarseness and

dry cough). If coughing persists, consult a

healthcare professional.

Dosage and Administration

Directions

Directions for kids cough apple:

For best results, begin taking one

KIdsCough at the first sign of a cough or sore throat.

Suck KidsCough and avoid chewing as it reduces

absorption of active ingredients. Recommended dosage 3 per day.

Use only when symptoms exist. Not to be used

in children under 2 years of age without medical advice.

Directions for kids cough orange:

For best results, begin taking one

KidsCough at the first sign of a cough or sore throat.

Suck KidsCough and avoid chewing as it reduces

absorption of active ingredients. Recommended dosage 3 per day.

Use only when symptoms exist. Not to be used

in children under 2 years of age without medical advice.

Directions for kids cough raspberry:

For best results, begin taking one

KidsCough at the first sign of a cough or sore throat.

Suck KidsCough and avoid chewing as it reduces

absorption of active ingredients. Recommended dosage 3 per day.

Use only when symptoms exist. Not to be used

in children under 2 years of age without medical advice.

Description

Non-Active Ingredients Non-active ingredients for kids cough apple: Isomalt, Natural Apple Flavour, Natural Colours, Carokram and Vegetable (Blue Gardinea) Non-active ingredients for kids cough orange: Isomalt, Natural Orange and Colour (Annato), Non-active ingredients for kids cough raspberry: Isomalt, Natural Raspberry Flavour and Natural Colour Carmine (Cochineal)

Section 44425-7

Storage and Handling for kids cough apple:

STORE BELOW 30 C

Storage and Handling for kids cough orange:

STORE BELOW 30 C

Storage and Handling for kids cough raspberry:

STORE BELOW 30 C



Section 50565-1

Keep Out of Reach of Children for kids cough apple:

Keep this and all other medicine out of reach of children.

Keep Out of Reach of Children for kids cough orange:

Keep this and all other medicine out of reach of children.

Keep Out of Reach of Children for kids cough raspberry:

Keep this and all other medicine out of reach of children.

Section 51727-6

Non-Active Ingredients

Non-active ingredients for kids cough apple:

Isomalt, Natural Apple Flavour, Natural

Colours, Carokram and Vegetable (Blue Gardinea)

Non-active ingredients for kids cough orange:

Isomalt, Natural Orange and Colour (Annato),

Non-active ingredients for kids cough raspberry:

Isomalt, Natural Raspberry Flavour and Natural

Colour Carmine (Cochineal)

Section 51945-4

Section 55105-1

Indications

Indications for kids cough apple:

For natural, temporary relief of cough and

sore throat symptoms (hoarseness and dry cough).

Indications for kids cough orange:

For natural, temporary relief of cough and

sore throat symptoms (hoarseness and dry cough).

Indications for kids cough raspberry:

For natural, temporary relief of cough and

sore throat symptoms (hoarseness and dry cough).

Section 55106-9

Active Ingredients for kids cough apple:

Each lozenge contains:

Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

Belladonna 30C

in equal quantities.

Active Ingredients for kids cough orange:

Each lozenge contains:

Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

Belladonna 30C

in equal quantities.

Active Ingredients for kids cough raspberry:

Each lozenge contains:

Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

Belladonna 30C

in equal quantities




Structured Label Content

Indications and Usage (34067-9)

Indications for kids cough apple:

For natural, temporary relief of cough

and sore throat symptoms (hoarseness and

dry cough). If coughing persists,

consult a heathcare professional.

Indications for kids cough orange:

For natural, temporary relief of cough

and sore throat symptoms (hoarseness and

dry cough). If coughing persists,

consult a healthcare professional.

Indications for kids cough raspberry:

For natural, temporary relief of cough

and sore throat symptoms (hoarseness and

dry cough). If coughing persists, consult a

healthcare professional.

Dosage and Administration (34068-7)

Directions

Directions for kids cough apple:

For best results, begin taking one

KIdsCough at the first sign of a cough or sore throat.

Suck KidsCough and avoid chewing as it reduces

absorption of active ingredients. Recommended dosage 3 per day.

Use only when symptoms exist. Not to be used

in children under 2 years of age without medical advice.

Directions for kids cough orange:

For best results, begin taking one

KidsCough at the first sign of a cough or sore throat.

Suck KidsCough and avoid chewing as it reduces

absorption of active ingredients. Recommended dosage 3 per day.

Use only when symptoms exist. Not to be used

in children under 2 years of age without medical advice.

Directions for kids cough raspberry:

For best results, begin taking one

KidsCough at the first sign of a cough or sore throat.

Suck KidsCough and avoid chewing as it reduces

absorption of active ingredients. Recommended dosage 3 per day.

Use only when symptoms exist. Not to be used

in children under 2 years of age without medical advice.

Warnings and Precautions (34071-1)

Warning:

Warning for kids cough apple:

If symptoms persist or suddenly worsen, consult your

healthcare specialist.

Warning for kids cough orange:

If symptoms persist or suddenly worsen, consult your

healthcare specialist.

Warning for kids cough raspberry:

If symptoms persist or suddenly worsen, consult your

healthcare specialist.

Section 44425-7 (44425-7)

Storage and Handling for kids cough apple:

STORE BELOW 30 C

Storage and Handling for kids cough orange:

STORE BELOW 30 C

Storage and Handling for kids cough raspberry:

STORE BELOW 30 C



Section 50565-1 (50565-1)

Keep Out of Reach of Children for kids cough apple:

Keep this and all other medicine out of reach of children.

Keep Out of Reach of Children for kids cough orange:

Keep this and all other medicine out of reach of children.

Keep Out of Reach of Children for kids cough raspberry:

Keep this and all other medicine out of reach of children.

Section 51727-6 (51727-6)

Non-Active Ingredients

Non-active ingredients for kids cough apple:

Isomalt, Natural Apple Flavour, Natural

Colours, Carokram and Vegetable (Blue Gardinea)

Non-active ingredients for kids cough orange:

Isomalt, Natural Orange and Colour (Annato),

Non-active ingredients for kids cough raspberry:

Isomalt, Natural Raspberry Flavour and Natural

Colour Carmine (Cochineal)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Indications

Indications for kids cough apple:

For natural, temporary relief of cough and

sore throat symptoms (hoarseness and dry cough).

Indications for kids cough orange:

For natural, temporary relief of cough and

sore throat symptoms (hoarseness and dry cough).

Indications for kids cough raspberry:

For natural, temporary relief of cough and

sore throat symptoms (hoarseness and dry cough).

Section 55106-9 (55106-9)

Active Ingredients for kids cough apple:

Each lozenge contains:

Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

Belladonna 30C

in equal quantities.

Active Ingredients for kids cough orange:

Each lozenge contains:

Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

Belladonna 30C

in equal quantities.

Active Ingredients for kids cough raspberry:

Each lozenge contains:

Drosera 30C, Spongia 30C, Kali Carbonicum 30C,

Phospherous 30C, Ipercacuanha 30C, Pulsatilla 30C,

Belladonna 30C

in equal quantities




Advanced Ingredient Data


Raw Label Data

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