Active Ingredient
Guaifenesin 400 mg
Respiratory Relief Tablet
FDA Label NDC 53499-5295
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 Respiratory Relief (NDC 53499-5295). 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, inactive ingredients, dosage & administration, purpose, indications & usage, warnings, ask a 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
Carnauba Wax
Cellulose
Glycerin
Hypromellose
Magnesium Stearate
Maltodextrin
Povidone
Silica
Sodium Croscarmellose
Stearic Acid
Dosage & Administration
Adults & children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not to exceed 6 tablets in 24 hours.
Children under 12 years of age: do not use.
Purpose
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Indications & Usage
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings
Do not use for children under 12 years of age.
Ask A 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 accompanied by excessive phlegm (mucus).
Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, tends to recur, or is accompanied by a fever, rash or persisient headache.
A persistent cough may be a sign of a serious condition.
Keep Out Of Reach Of Children
Keep out of reach of children.
Pregnant Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Overdosage:
In case of overdose, seek medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
