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 Cold And Throat (NDC 64997-400). 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 for Cough:
Isomalt, Natural Orange Oil, Natural Colour E160C
Non-Active Ingredients for Cold:
Isomalt, Citric Acid, Flavours,
Bixa Orellana (annatto) seed powder,
turmeric, cabbage.
Non-Active Ingredients for Throat:
Isomalt, Natural Pine-Lime Flavour,
Natural Colour, Turmeric.
Active Ingredients
Each Lozenge Contains for kids cough:
Drosera 30C, Spongia 30C, Kali Carbonicum 30C,
Phospherous 30C, Ipeacacuanha 30C,
Pulsatilla 30C, Belladonna 30C
in equal quantities
Each Lozenge Contains for kids cold:
Alium Cepa 30C, Kali Bichromicum 30C,
Kali Sulphuricum 30C, Nux Vomica 30C,
Natrum Muriaticum 30C, Pulsatilla
30C, Silcea 30C, in equal quantities.
Each Lozenge contains for kids throat:
Aconite 30C, Belladonna 30C, Chamomilla
30C, Phytolacca 30C, in equal quantities.
Indications for kids cough:
For natural, temporary relief of pain and
discomfort of Cough, Cold and Throat symptoms.
Indications for kids cold:
For natural, temporary relief of pain and
discomfort of Cough, Cold and Throat symptoms.
Indications for kids throat:
For natural, temporary relief of pain and
discomfort of Cough, Cold and Throat symptoms.
Warning for kids cough:
Warning: If symptoms persist or worsen suddenly, consult your health-
care specialist. Keep this and all other medicine out of reach of children.
Warning for kids cold:
Warning: If symptoms persist or worsen suddenly, consult your health-
care specialist. Keep this and all other medicine out of reach of children.
Warning for kids throat:
Warning: If symptoms persist or worsen suddenly, consult your health-
care specialist. Keep this and all other medicine out of reach of children.
Keep Out of Reach of Children for kids cough:
Keep this and all other medicine out of reach of children.
Keep Out of Reach of Children for kids cold:
Keep this and all other medicine out of reach of children.
Keep Out of Reach of Children for kids throat:
Keep this and all other medicine out of reach of children.
Directions for kids cough:
Suck one Kids lozenge at the first
sign of discomfort. There is no need to finish the whole
lozenge as the therapeutic benefit of the medicine will be
gained in the first few licks or sucks.
The recommended dose is 3 lozenges per day. Not to be
used by children under 2 years of age without medical advice
or supervision.
Directions for kids cold:
Suck one Kids lozenge at the first
sign of discomfort. There is no need to finish the whole
lozenge as the therapeutic benefit of the medicine will be
gained in the first few licks or sucks.
The recommended dose is 3 lozenges per day. Not to be
used by children under 2 years of age without medical advice
or supervision.
Directions for kids throat:
Suck one Kids lozenge at the first
sign of discomfort. There is no need to finish the whole
lozenge as the therapeutic benefit of the medicine will be
gained in the first few licks or sucks.
The recommended dose is 3 lozenges per day. Not to be used
by children under 2 years of age without medical advice or
supervision.
Indications for kids cough:
For natural, temporary relief of pain and
discomfort of Cough, Cold and Throat symptoms.
Indications for kids cold:
For natural, temporary relief of pain and
discomfort of Cough, Cold and Throat symptoms.
Indications for kids throat:
For natural, temporary relief of pain and
discomfort of Cough, Cold and Throat symptoms.
Storage for kids cough:
STORE BELOW 30 C
Storage for kids cold:
STORE BELOW 30 C
Storage for kids throat:
STORE BELOW 30 C
Copy Of Label (Multipak Three)
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