Sambucus Cold Flu Relief Elderberry Syrup
FDA Label NDC 53499-1513

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America for the product Sambucus Cold Flu Relief Elderberry (NDC 53499-1513). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, indications & usage, dosage & administration, purpose, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

Ethyl Alcohol 

Glycerin

Lactose Monohydrate

Maltodextrin

Natural Flavor

Potassium Sorbate

Purified Water

Sorbitol

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, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.

Dosage & Administration

Directions:

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

Shake well before each use.

Use only with enclosed dosage cup.

Adults & children 13 years of age and older: take 1½ teaspoons (tsp) (7.5 mL) three times daily.

Children 6 to 12 years of age: take 1 teaspoon (tsp) (5mL) three times daily.

Children under 6 years of age: consult a doctor.

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, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.

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 then 7 days or occurs with rash or persistent headache. 

These could be signs of a serious condition.

Pregnancy Or Breastfeeding

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.

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