Other
Drug Facts
PAC
Pharma Associate
Consulting, LLC
Guntersville, AL 35976
Klernaz
FDA Label NDC 69140-620
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Associate Consultants, Inc for the product Klernaz (NDC 69140-620). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - ask doctor, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Dextromethorphan HBr 15 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Indications & Usage
Uses: temporarily relieves these symptoms occurring with a cold nasal decongestion: cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Warnings
Warnings:
- when using this product do not exceed recommended dose.
- 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.
Otc - Stop Use
Stop use and ask a doctor if:
- symptoms do not improve
- new symptoms occur
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
- cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Dosage & Administration
Directions:
Adults and children 12 years of age and older
- Take 1 tablet every 4-6 hours as needed, do not exceed 4 tablets in 24 hours, or as directed by a doctor.
- Take 1/2 tablet every 4-6 hours as needed, do not exceet 2 tablets in 24 hours, or as directed by a doctor.
Children 6-12 years:
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Inactive Ingredient
Colloidal Silicon Dioxide, F&C Blue # 2, Microcrystalline Cellulose, Stearic Acid
Storage And Handling
Other information:
- Do not use if there are signs of tampering
- Store at Controlled Room Temperature 15°-30°C (59°-86°F)
Principal Display Panel - 30 Tablets Bottle Labeling
NDC 69140-0620-03
Klernaz
TABLETS
TRIPLE COMBINATION RELIEF:
Expectorant: Guaifenesin 400MG
Decongestant: Phenylephrine HCL 10MG
Cough Suppressant: Dextromethorphan HBR 15MG
30 Tablets
* Please review the disclaimer below.
