SAMBUCUS COLD FLU RELIEF ELDERBERRY- pelargonium sidoides root, aconitum napellus, eucalyptus globulus leaf, sambucus nigra flowering top, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, phosphorus, ipecac powder

Sambucus Cold Flu Relief Elderberry by

Drug Labeling and Warnings

Sambucus Cold Flu Relief Elderberry by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., Universal Synergetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Sambucus nigra 3X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X 

Ipecacuanha 3X 

Inactive Ingredients

Citric Acid

Elderberry Extract

Lactose Monohydrate

Maltodextrin

Natural Flavors

Silica

Xylitol

Dosage & Administration

Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.

For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults and children 13 years of age and older: Take 1 packet three times daily.

Children 6-12 years of age: Take 1 packet two times daily.

Children under 6 years of age: Consult a doctor.

Indications & Usage

Temporarily relieves flu symptoms.

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. 

Purpose

Temporarily relieves flu symptoms.

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.

Warnings

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Pregnant or breast feeding

If pregnant or breast-feeding, ask a healthcare professional before use. 

Keep out of reach of children.

Keep out of reach of children.

Overdose

In case of overdose, seek medical help or contact a Poison Control Center right away. 

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SAMBUCUS COLD FLU RELIEF ELDERBERRY 
pelargonium sidoides root, aconitum napellus, eucalyptus globulus leaf, sambucus nigra flowering top, bryonia alba root, eupatorium perfoliatum flowering top, gelsemium sempervirens root, phosphorus, ipecac powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5182
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]  in 5.3 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]  in 5.3 g
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	2 [hp_X]  in 5.3 g
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]  in 5.3 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]  in 5.3 g
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 5.3 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 5.3 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]  in 5.3 g
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]  in 5.3 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (NATURAL LEMON FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5182-0	10 in 1 CARTON	01/10/2025
1		5.3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/10/2025

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-5182)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Synergetics, Inc.		069033371	pack(53499-5182)