KLERNAZ- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet

Klernaz by

Drug Labeling and Warnings

Klernaz by is a Otc medication manufactured, distributed, or labeled by Pharma Associate Consultants, Inc, TG United. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Dextromethorphan HBr 15 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

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.

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.

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.

Children 6-12 years:

• Take 1/2 tablet every 4-6 hours as needed, do not exceet 2 tablets in 24 hours, or as directed by a doctor.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional before use.

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)

SPL UNCLASSIFIED SECTION

PAC

Pharma Associate

Consulting, LLC

Guntersville, AL 35976

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

INGREDIENTS AND APPEARANCE

KLERNAZ 
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69140-620
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69140-620-03	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/07/2015

Labeler - Pharma Associate Consultants, Inc (079418551)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		172837085	manufacture(69140-620)