NDC Code(s) : 53499-9159-0
Packager : Schwabe North America, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Umcka Cold Flu Berry ChewablePelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53499-9159
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PELARGONIUM SIDOIDES ROOT(UNII: H6J53HEX8E)
(PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) 		PELARGONIUM SIDOIDES ROOT1 [hp_X]
ACONITUM NAPELLUS(UNII: U0NQ8555JD)
(ACONITUM NAPELLUS - UNII:U0NQ8555JD) 		ACONITUM NAPELLUS4 [hp_X]
BRYONIA ALBA ROOT(UNII: T7J046YI2B)
(BRYONIA ALBA ROOT - UNII:T7J046YI2B) 		BRYONIA ALBA ROOT4 [hp_X]
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
(EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) 		EUCALYPTUS GLOBULUS LEAF2 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP(UNII: 1W0775VX6E)
(EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) 		EUPATORIUM PERFOLIATUM FLOWERING TOP2 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT(UNII: 639KR60Q1Q)
(GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) 		GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
IPECAC(UNII: 62I3C8233L)
(IPECAC - UNII:62I3C8233L) 		IPECAC3 [hp_X]
PHOSPHORUS(UNII: 27YLU75U4W)
(PHOSPHORUS - UNII:27YLU75U4W) 		PHOSPHORUS6 [hp_X]
Inactive Ingredients
Ingredient Name Strength
ANNATTO(UNII: 6PQP1V1B6O)
BEET JUICE(UNII: IOZ32L9H3O)
CARAMEL(UNII: T9D99G2B1R)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALIC ACID(UNII: 817L1N4CKP)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MANNITOL(UNII: 3OWL53L36A)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SORBITOL(UNII: 506T60A25R)
STEARIC ACID(UNII: 4ELV7Z65AP)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color pink (pink with pinkish-purple specks) Score no score
Shape ROUND (C) Size 16 mm
Flavor BERRY Imprint Code C
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53499-9159-02 in 1 CARTON 12/01/2016
110 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/01/2016 01/31/2019

PRINCIPAL DISPLAY PANEL

15159_05_UMCKA Berry Chewable

15159_05_UMCKA Berry Chewable.jpg

15159_05_UMCKA Berry Chewable.jpg