NDC | 64997-100-01, 64997-100-02 |
Set ID | b0392020-d97d-4a6b-8912-b22f8da8f68a |
Category | HUMAN OTC DRUG LABEL |
Packager | KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
Suck one Kids throat lozenge at the
first sign of throat pain or 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 & USAGE
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KIDS THROAT
aconite 30c, belladonna 30c, chamomilla 30c, phytolacca 30c lozengeProduct Information Product Type HUMAN OTC DRUG 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 10 in 1 BOX 2 NDC:64997-100-02 10 in 1 BOX 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(64997-100)