NDC Code(s) : 53499-0393-5, 53499-0393-9
Packager : Schwabe North America, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Cough and BronchialANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, STAR ANISE SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53499-0393
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIMONY PENTASULFIDE(UNII: 1433F1I86N)
(ANTIMONY PENTASULFIDE - UNII:1433F1I86N) 		ANTIMONY PENTASULFIDE6 [hp_X] in 237 mL
BRYONIA ALBA ROOT(UNII: T7J046YI2B)
(BRYONIA ALBA ROOT - UNII:T7J046YI2B) 		BRYONIA ALBA ROOT3 [hp_X] in 237 mL
DROSERA ROTUNDIFOLIA FLOWERING TOP(UNII: 75O014T1HG)
(DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) 		DROSERA ROTUNDIFOLIA FLOWERING TOP3 [hp_X] in 237 mL
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
(EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) 		EUCALYPTUS GLOBULUS LEAF3 [hp_X] in 237 mL
IPECAC(UNII: 62I3C8233L)
(IPECAC - UNII:62I3C8233L) 		IPECAC4 [hp_X] in 237 mL
STAR ANISE(UNII: XKC1657P78)
(STAR ANISE - UNII:XKC1657P78) 		STAR ANISE1 [hp_X] in 237 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ARONIA MELANOCARPA FRUIT JUICE(UNII: D2EVP827PJ)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FRUCTOSE(UNII: 6YSS42VSEV)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53499-0393-51 in 1 BOX 07/01/2004
1119 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:53499-0393-91 in 1 BOX 07/01/2004
2237 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2004 04/30/2019

PRINCIPAL DISPLAY PANEL

Package Label:

21900393  4 oz

21900594  8 oz

21900594_BT_CHILD_COUGH_B04.jpg