COLD RELIEF DAY PLUS NIGHT- cold relief day plus night 
Schwabe North America, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Cold Relief Day Plus Night

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.

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COLD RELIEF  DAY PLUS NIGHT
cold relief day plus night kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-2060
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-2060-11 in 1 CARTON05/22/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 5 g
Part 21 POUCH 5 g
Part 1 of 2
COLD RELIEF  DAY
cold relief day powder
Product Information
Item Code (Source)NDC:53499-2040
Route of AdministrationOral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 5 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TURMERIC (UNII: 856YO1Z64F)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON, CITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-2040-18 in 1 PACKAGE
15 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/22/2024
Part 2 of 2
COLD RELIEF  NIGHT
cold relief night powder
Product Information
Item Code (Source)NDC:53499-2050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 5 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]  in 5 g
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A) ( HUMULUS LUPULUS WHOLE - UNII:912A6Q1N4A) HUMULUS LUPULUS WHOLE1 [hp_X]  in 5 g
PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) ( PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO) PASSIFLORA INCARNATA WHOLE1 [hp_X]  in 5 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-2050-14 in 1 PACKAGE
15 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/22/2024
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-2060)
Establishment
NameAddressID/FEIBusiness Operations
ProSolutions, Inc.070769782label(53499-2060) , pack(53499-2060)

Revised: 5/2024
Document Id: 1e8f99e1-d1b7-4150-8845-6aa1d63b984d
Set id: 9b063242-ffd6-48f8-af1e-14bcea5247ec
Version: 2
Effective Time: 20240523
 
Schwabe North America, Inc.