NATURES WAY COLD RELIEF HOT DRINK- pelargonium sidoides whole, pelargonium sidoides whole, matricaria chamomilla root, hops, passiflora incarnata whole kit

Natures Way Cold Relief Hot Drink by

Drug Labeling and Warnings

Natures Way Cold Relief Hot Drink by is a Otc medication manufactured, distributed, or labeled by Universal Synergetics, Inc, Universal Synergetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts (Day)

Active ingredient (in each packet)

Pelargonium sidoides1X

Purpose

Shortens duration and reduces severity of upper respiratory symptoms

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

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 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 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.

If pregnant or breast-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 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 Umcka® 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

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, maltodextrin, natural flavor, silica, turmeric color, xylitol

Questions?

1-800-962-8873 / naturesway.com

Drug Facts(Night)

Active ingredients (in each packet)

Pelargonium sidoides 1X
Chamomilla recutita 2X
Humulus lupulus 1X
Passiflora incarnata 1X

Purpose

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

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 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 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.

If pregnant or breast-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 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 Umcka® Cold Relief Hot Drink Day 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

Inactive ingredients

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

Package Labeling:

Package Labeling:Day

Package Labeling:Night

INGREDIENTS AND APPEARANCE

NATURES WAY COLD RELIEF HOT DRINK 
pelargonium sidoides whole, pelargonium sidoides whole, matricaria chamomilla root, hops, passiflora incarnata whole kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80228-2060

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80228-2060-1	1 in 1 KIT	06/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	8 PACKET	40 g
Part 2	4 PACKET	20 g

Part 1 of 2

NATURES WAY COLD RELIEF DAY FORMULA LEMON FLAVORED 
pelargonium sidoides whole powder

Product Information
Item Code (Source)	NDC: 80228-2040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES WHOLE (UNII: 4FY2944729) (PELARGONIUM SIDOIDES WHOLE - UNII:4FY2944729)	PELARGONIUM SIDOIDES WHOLE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80228-2040-1	5 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 drug other		06/01/2025

Part 2 of 2

NATURES WAY COLD RELIEF NIGHT FORMULA HONE-LEMON FLAVORED 
pelargonium sidoides whole, matricaria chamomilla root, hops, passiflora incarnata whole powder

Product Information
Item Code (Source)	NDC: 80228-2050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES WHOLE (UNII: 4FY2944729) (PELARGONIUM SIDOIDES WHOLE - UNII:4FY2944729)	PELARGONIUM SIDOIDES WHOLE	1 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA ROOT (UNII: BTG5H50X7F) (MATRICARIA CHAMOMILLA ROOT - UNII:BTG5H50X7F)	MATRICARIA CHAMOMILLA ROOT	2 [hp_X]  in 1 g
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	1 [hp_X]  in 1 g
PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) (PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO)	PASSIFLORA INCARNATA WHOLE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HONEY (UNII: Y9H1V576FH)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80228-2050-1	5 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 drug other		06/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2025

Labeler - Universal Synergetics, Inc (069033371)

Registrant - Universal Synergetics, Inc. (069033371)