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 tablet, chewable

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., Schwabe North America, Inc, Thermo-Pak Company, 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 Ingredient

Annatto Seed Extract Color

Beet Juice Color

Caramel Color

Elderberry Extract

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sodium Croscarmellose

Sorbitol

Stearic Acid

Xylitol

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.

Dosage and Administration

Directions

Chew or dissolve tablets in the mouth.  Do not swallow whole.

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 chewable tablet three times daily.
Children 6-12 years of age: Take 1 chewable tablet two times daily.
Children under 6 years of age: Consult a doctor.

Warnings

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 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.

Pregnancy or breast feeding

If you are 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 tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5175
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]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	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]
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]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ANNATTO (UNII: 6PQP1V1B6O)
BEET JUICE (UNII: IOZ32L9H3O)
CARAMEL (UNII: T9D99G2B1R)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	pink (pink with pinkish-purple specks)	Score	no score
Shape	ROUND (C)	Size	16mm
Flavor	BERRY (NATURAL BERRY FLAVOR)	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5175-0	2 in 1 CARTON	12/11/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/11/2024

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-5175)

Establishment
Name	Address	ID/FEI	Business Operations
Thermo-Pak Company, Inc.		079689440	pack(53499-5175)