Active Ingredients
Pelargonium sidoides 1X
Aconitum napellus 3X
Bryonia 3X
Hepar sulphuris calcareum 6C
Stannum metallicum 6C
Spongia tosta 3X
Cough Relief Syrup
FDA Label NDC 53499-6864
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Cough Relief (NDC 53499-6864). 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 ingredients, inactive ingredients, purpose, indications & usage, doage & administration, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Citric Acid
English Ivy Leaf Extract
Ethyl Alcohol
Glycerin
Lactose Monohydrate
Maltodextrin
Potassium Sorbate
Purified Water
Sorbitol
Purpose
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion.
Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.
Indications & Usage
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion.
Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.
Doage & Administration
Directions
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Shake well before each use.
Use only with enclosed dosage cup.
Adults and Children 13 years of age and older: Take 1 ½ teaspoons (tsp) (7.5 mL) three times daily.
Children 6 to 12 years of age: Take 1 teaspoon (5 mL) three times daily.
Children under 6 years of age: Consult a doctor.
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 Doctor
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 Genaniaceae family.
Stop Use
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 a sign of a serious condition.
Overdose
In case of overdose, seek medical help or contact a Poison Control Center right away.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
* Please review the disclaimer below.
