Label: UMCKA ELDERBERRY - aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, pelargonium sidoides root, phosphorus and sambucus nigra flowering top 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Aconitum napellus 4x HPUS
Bryonia alba 4x HPUS
Eucalyptus globulus 2x HPUS
Eupatorium perfoliatum 2x HPUS
Gelsemium sempervirens 4x HPUS
Ipecacuanha 3x HPUS
Pelargonium sidoides 1x HPUS
Phosphorus 6x HPUS
Sambucus nigra 3x HPUSClose
- 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 Umcka Elderberry
- INGREDIENTS AND APPEARANCE
umcka elderberry syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5845 Route of Administration ORAL DEA Schedule 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 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 1 120 mL in 1 BOTTLE 2 NDC:53499-5845-7 10 mL in 1 BOTTLE 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)