Label: UMCKA ELDERBERRY- umcka elderberry syrup
- NDC Code(s): 53499-5845-4, 53499-5845-7
- Packager: Nature's Way Holding Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Updated October 6, 2016
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- ACTIVE INGREDIENT
Aconitum napellus 4x
Bryonia alba 4x
Eucalyptus globulus 2x
Eupatorium perfoliatum 2x
Gelsemium sempervirens 4x
Pelargonium sidoides 1x
Sambucus nigra 3xClose
- INACTIVE INGREDIENT
Natural Raspberry flavor
- INDICATIONS & USAGE
Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations.Close
- DOSAGE & ADMINISTRATION
For best results, use at first sign of symptoms.
Continue to use for an additional 48 hours after symptoms cease.Close
Adults and children 12 years of age and older: take 1 1/2 teaspoons (7.5 mL) three times daily.
Children 6 to 11 years of age: take 1 teaspoon (5mL) three times daily.
Children under 6 years of age: consult a doctor.
Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if: new symptoms occur, symptoms get worse or last more then 7 days, cough lasts more then 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.
These could be signs of a serious condition.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a healthcare professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.Close
Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations:
chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny noseClose
- PRINCIPAL DISPLAY PANEL
15845_04 UMCKA Elderberry.jpg
- INGREDIENTS AND APPEARANCE
umcka elderberry syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5845 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] in 120 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X] in 120 mL EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] in 120 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 2 [hp_X] in 120 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X] in 120 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X] in 120 mL PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 120 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X] in 120 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] in 120 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EUROPEAN ELDERBERRY (UNII: BQY1UBX046) LACTOSE (UNII: J2B2A4N98G) MALTODEXTRIN (UNII: 7CVR7L4A2D) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor BERRY (RASPBERRY AND ELDERBERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-5845-4 1 in 1 BOX 10/01/2012 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:53499-5845-7 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2012 09/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/01/2012 Labeler - Nature's Way Holding Co (153970520) Establishment Name Address ID/FEI Business Operations Schwabe North America 831153908 manufacture(53499-5845)