NDC | 53499-9779-3 |
Set ID | 48bdfe6b-53b7-4298-b64f-3c2b12fa01e0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Schwabe North America, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
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Dosage & Administration
Directions:
Chew or dissolve lozenges in the mouth.
Do not swallow lozenges whole.
For best results, use at the first sign of symptoms:
Adults and children 12 years of age and older: Take 1 chewable lozenge four times daily.
Children 6-11 years of age: Take 1 chewable lozenges two times daily.
Children under 6 years of age: Consult a physician. - Indications & Usage
- Purpose
- Warnings
- Ask doctor
- Stop Use
- Pregnant or Breast feeding
- Overdosage
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SAMBUCUS FLUCARE
aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus, sambucus nigra flowering top lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9779 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X] Inactive Ingredients Ingredient Name Strength EUROPEAN ELDERBERRY (UNII: BQY1UBX046) FRUCTOSE (UNII: 6YSS42VSEV) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MALIC ACID (UNII: 817L1N4CKP) MANNITOL (UNII: 3OWL53L36A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color purple Score no score Shape ROUND Size 16mm Flavor GRAPE (NATURAL GRAPE FLAVOR) Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-9779-3 1 in 1 CARTON 09/08/2017 1 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/08/2017 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc. 831153908 manufacture(53499-9779)