The following Structured Product Label (SPL) was submitted to the FDA by Keysun Pty. Limited Also Traded As Keysun Laboratories for the product Kids Cough (NDC 64997-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredient, otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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)
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
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).
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.
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.
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.
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.
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
Copy Of Label (Multipak Cough)
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