COLD RELIEF DAY PLUS NIGHT kit

Cold Relief by

Drug Labeling and Warnings

Cold Relief by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc., ProSolutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Cold Relief Day:

Pelargonium sidoides 1X

Cold Relief Night:

Pelargonium sidoides 1X

Chamomilla recutita 2X

Humulus lupulus 1X

Passiflora incarnata 1X

Inactive Ingredient

Cold Relief Day: Citric Acid, Maltodextrin, Natural Flavor, Silica, Turmeric Color, Xylitol.

Cold Relief Night: Citric Acid, Honey, Lactose Monohydrate, Lou Han Guo, Maltodextrin, Natural Flavor, Silica, Stevia Leaf Extract, Turmeric Color, Xylitol.

Dosage & Administration

Directions

Cold Relief Day: 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.

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

Cold Relief Night: 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 Day Formula at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

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

Indications & Usage

Cold Relief Day: 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

Cold Relief Night: 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

Purpose

Cold Relief Day: 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

Cold Relief Night: 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

Cold Relief Day: 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.

Cold Relief Night: 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

Cold Relief Day: 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.

Cold Relief Night: 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

Cold Relief Day: 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.

Cold Relief Night: 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

Cold Relief Day: If pregnant or breast-feeding, ask a healthcare professional before use.

Cold Relief Night: If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children.

Cold Relief Day: Keep out of reach of children.

Cold Relief Night: Keep out of reach of children.

Overdose

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

Cold Relief Night: 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

COLD RELIEF  DAY PLUS NIGHT
cold relief day plus night kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-2060

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2060-1	1 in 1 CARTON	05/22/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	5 g
Part 2	1 POUCH	5 g

Part 1 of 2

COLD RELIEF  DAY
cold relief day powder

Product Information
Item Code (Source)	NDC: 53499-2040
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]  in 5 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TURMERIC (UNII: 856YO1Z64F)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON, CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2040-1	8 in 1 PACKAGE
1		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/22/2024

Part 2 of 2

COLD RELIEF  NIGHT
cold relief night powder

Product Information
Item Code (Source)	NDC: 53499-2050
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]  in 5 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	2 [hp_X]  in 5 g
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) ( HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A)	HUMULUS LUPULUS WHOLE	1 [hp_X]  in 5 g
PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) ( PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO)	PASSIFLORA INCARNATA WHOLE	1 [hp_X]  in 5 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)
STEVIA LEAF (UNII: 6TC6NN0876)
TURMERIC (UNII: 856YO1Z64F)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2050-1	4 in 1 PACKAGE
1		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/22/2024

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-2060)

Establishment
Name	Address	ID/FEI	Business Operations
ProSolutions, Inc.		070769782	label(53499-2060) , pack(53499-2060)