Label: COLD RELIEF DAY PLUS NIGHT kit
- NDC Code(s): 53499-2040-1, 53499-2050-1, 53499-2060-1
- Packager: Schwabe North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated May 23, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredient
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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
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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
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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
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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.
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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.
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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
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD RELIEF DAY PLUS NIGHT
cold relief day plus night kitProduct 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 powderProduct 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 powderProduct 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)
