The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Cough And Mucus Night (NDC 70163-0024). 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 active ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each drop) 5.24% of Antimonium Tartaricum 6X, 12X, 30X, Avena Sativa 8X, Bryonia 6X, 12X, Chamomilla 8X, Drosera 6X, Hepar Sulphuris Calcareum 12X, Hydrastis Canadensis 5X, 30X, Kali Bichromicum 12X, 30X, Passiflora Incarnata 6X, Pulsatilla 6X, Sambucus Nigra 6X, Stannum Metallicum 12X, 30X, Sulphur 12X; 0.10% of Sambucus Nigra 3X.
Antimonium Tartaricum – thick mucus, Avena Sativa - sleeplessness, Bryonia – hacking cough, Chamomilla – sleeplessness, rattling mucus in chest, Drosera – cough worse at night, Hepar Sulphuris Calcareum – cough, stubborn mucus in chest, Hydrastis Canadensis – cough with thick yellow expectoration, Kali Bichromicum – cold with thick nasal discharge, Passiflora Incarnata – nighttime cough, Pulsatilla – cough with yellow expectoration, Sambucus Nigra – cough worse at night, Stannum Metallicum – deep productive cough triggered by mucus in the throat, Sulphur – chest congestion*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May help temporarily relieve ■ chest congestion ■ hacking cough ■ thick mucus in chest, throat and nose*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Do not use
■ for persistent or chronic cough such as occurs with asthma ■ if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Stop use and ask a doctor if
■ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache.
These could be signs of a serious condition
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is missing or open.
■ Store tightly closed at room temperature (65-80°F)
In case of overdose, get medical help or contact a Poison Control Center right away.
■ children and infants over 4 months of age place 1/2 teaspoon (2.5 ml) under the tongue every 20 min until symptoms improve, then every 4 hours as needed.
■ for children under 4 months consult a healthcare professional.
citric acid, glycerin, natural mixed berry flavor, purified water, sodium benzoate
Dist. By NaturalCare
201 Apple Blvd.
Woodbine, IA 51579
www.NaturalCareWorks.com
1-888-280-5672
NaturalCare
children's
Cough & Mucus
Night
Homeopathic
4 FL OZ (120 mL)
* Please review the disclaimer below.
