Active Ingredient (In Each 5 Mltsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 5 mg
Cough Formula Cough And Cold
FDA Label NDC 53807-531
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Cough Formula Cough And Cold (NDC 53807-531). 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 (in each 5 mltsp), purpose, uses, do not use, otc - ask doctor, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to to drain bronchial tubes
temporarily relieves these symptoms occuring with a cold
nasal congestion
cough due to minor throat and bronchial irritation
Do Not Use
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - When Using
When using this product do not use more than directed.
Stop Use And Ask A Doctor If
- you get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
| age | dose |
|---|---|
| adults and children 12 years and over | 2 teaspoonfuls every 4 hours |
| children 6 years to under 12 years | 1 teaspoonful every 4 hours |
| children 2 years to under 6 years | 1/2 teaspoonful every 4 hours |
| children under 2 years | ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
- store at room temperature 15° - 30°C (59° - 86°F)
- alocohol free
- not a USP elixir
- each teaspoon (5 mL) contains: sodium 2 mg.
Inactive Ingredients
citric acid, FD&C red no. 40, , flavors, glycerin, menthol, propylene glycol, sodium benzoate, sodium saccharin, water
* Please review the disclaimer below.
