Natures Way Cold Relief Hot Drink Kit
FDA Label NDC 80228-2060
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 Natures Way Cold Relief Hot Drink (NDC 80228-2060). 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 (day), active ingredient (in each packet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Packet)
Pelargonium sidoides1X
Purpose
Shortens duration and reduces severity of upper respiratory symptoms
Shortens duration and reduces severity of upper respiratory symptoms
Helps with restful sleep††
Uses
• Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:
• chest congestion • nasal congestion • cough • hoarseness • sore throat
•Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:
• chest congestion • nasal congestion • cough • hoarseness • sore throat
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
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
• 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
• 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 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.
• 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.
If Pregnant Or Breast-Feeding,
ask a healthcare professional before use.
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.
In case of overdose, seek medical help or contact a Poison Control Center right away.
Directions
• 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 with Cold Relief Hot Drink Night Formula 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 two times daily |
| children 6-12 years of age | take 1 packet daily |
| children under 6 years of age | consult a doctor |
• 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 with Cold Relief Hot Drink Night Formula 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 nightly 30-60 minutes before bed |
| children 6-12 years of age | take 1 packet nightly 30-60 minutes before bed |
| 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
•
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, maltodextrin, natural flavor, silica, turmeric color, xylitol
citric acid, honey, lactose monohydrate, luo han guo, maltodextrin, natural flavor, silica, stevia (leaf) extract, turmeric color, xylitol
Questions?
1-800-962-8873/ naturesway.com
1-800-962-8873/ naturesway.com
Active Ingredients (In Each Packet)
Pelargonium sidoides 1X
Chamomilla recutita 2X
Humulus lupulus 1X
Passiflora incarnata 1X
Package Labeling:
Kit (Kit)
* Please review the disclaimer below.
