Sambucus Cold Flu Relief Hot Drink Lemon Flavored Powder
FDA Label NDC 80228-5182

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Synergetics, Inc for the product Sambucus Cold Flu Relief Hot Drink Lemon Flavored (NDC 80228-5182). 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 drug facts, active ingredients (in each packet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor, if pregnant or brest-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Packet)

Pelargonium sidoides 1 X
Aconitum napellus 4X, Eucalyptus globulus 2X,
Sambucus nigra 3X
Bryonia 4X, Eupatorium perfoliatum 6X
Gelsemium sempervirens 4X, Phosphorus 6X
Ipecacuanha 3X

Purpose

Shortens duration and reduces severity of upper respiratory symptoms
Pain reliever/fever reducer++
Cough suppressant++
Sneezing/runny nose/sore throat++
Nasal decongestant++

Uses

  • 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 accompained or followed by a fever, headche, rash, nausea, or vomiting, consult a doctor promptly

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 accompained by excessive phlegm (mucus)
  • been taking any medications
  • an allergy to plants of the Geraniaceae family

Stop Use And Ask A Doctor

  • 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 sign of a serious condition.

If Pregnant Or Brest-Feeding,

ask a healthcare professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Dissolve contents of 1 packet in 4-6 ounes of hot water and sip while hot. May also be dissolved in 4-6 ounces of 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
    •  age dose
     adults & 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

Other Information

  • TAMPER EVIDENT.Packaged in individually sealed packets. Do not use if open or torn.
  • store at room temperature 20 25°C (68-77°F) in a dry place out of direct sunlight

Inactive Ingredients

citric acid, elderberry extract, lactose monohydrate, maltodextrin, natural flavours, silica, xylitol

Questions?

1-800-962-8873 / naturesway.com

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