| NDC | 64997-100-01, 64997-150-01, 64997-200-01, 64997-400-01 |
| Set ID | a8124d13-d8ea-4251-b537-dec77470595e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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INACTIVE INGREDIENT
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.
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ACTIVE INGREDIENT
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.
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PURPOSE
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.
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WARNINGS
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.
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KEEP 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.
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DOSAGE & ADMINISTRATION
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.
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INDICATIONS & USAGE
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 AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS COUGH COLD AND THROAT
drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64997-400 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64997-400-01 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 KIT 4 Part 2 1 KIT 4 Part 3 1 KIT 4 Part 1 of 3 KIDS COUGH
drosera 30c, spongia 30c, kali carbonicum 30c, phospherous 30c, ipeacacuhuana 30c, pulsatilla 30c, belladonna 30c lozengeProduct Information Item Code (Source) NDC:64997-150 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROSERA INTERMEDIA (UNII: B3G4A96QLY) (DROSERA INTERMEDIA - UNII:B3G4A96QLY) DROSERA INTERMEDIA 30 [hp_X] SPONGIA OFFICINALIS WHOLE (UNII: 755U7L3M7Z) (SPONGIA OFFICINALIS WHOLE - UNII:755U7L3M7Z) SPONGIA OFFICINALIS WHOLE 30 [hp_X] POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 30 [hp_X] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_X] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_X] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 30 [hp_X] Inactive Ingredients Ingredient Name Strength ISOMALT (UNII: S870P55O2W) Product Characteristics Color orange (orange) Score no score Shape ROUND Size 31mm Flavor ORANGE (orange) Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64997-150-01 4 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2014 Part 2 of 3 KIDS COLD
allium cepa 30c, kali bichromium 30c, kali sulphuricum 30c, nux vomica 30c, natrum muriaticum 30c, pulsatilla 30c, silicea 30c lozengeProduct Information Item Code (Source) NDC:64997-200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 30 [hp_X] POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 30 [hp_X] POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE 30 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_X] SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_X] Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BIXA ORELLANA SEED (UNII: O87354RZ5A) TURMERIC (UNII: 856YO1Z64F) CABBAGE (UNII: GW0W1Y9I97) Product Characteristics Color red (red) Score no score Shape ROUND Size 31mm Flavor RASPBERRY (raspberry) Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64997-200-01 4 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2014 Part 3 of 3 KIDS THROAT
aconite 30c, belladonna 30c, chamomilla 30c, phytolacca 30c lozengeProduct Information Item Code (Source) NDC:64997-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_X] BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF 30 [hp_X] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_X] PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 30 [hp_X] Inactive Ingredients Ingredient Name Strength ISOMALT (UNII: S870P55O2W) Product Characteristics Color yellow (yellow) Score no score Shape ROUND Size 31mm Flavor LIME (Pine-Lime) Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64997-100-01 4 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2014 Labeler - KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES (751652405) Establishment Name Address ID/FEI Business Operations KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES 751652405 manufacture(64997-400)
