KLERNAZ- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet 
Pharma Associate Consultants, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Klernaz Tablets

Drug Facts

Active ingredient

Dextromethorphan HBr 15 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses: temporarily relieves these symptoms occurring with a cold nasal decongestion: cough due to minor throat and bronchial irritation

Warnings:

Stop use and ask a doctor if:

Ask a doctor before use if you have

Directions:

Adults and children 12 years of age and older

Children 6-12 years:

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

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.

Colloidal Silicon Dioxide, F&C Blue # 2, Microcrystalline Cellulose, Stearic Acid

Other information:

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

Klernaz Tablets

KLERNAZ 
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69140-620
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69140-620-0330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/07/2015
Labeler - Pharma Associate Consultants, Inc (079418551)
Establishment
NameAddressID/FEIBusiness Operations
TG United172837085manufacture(69140-620)

Revised: 8/2015
Document Id: 1cba7bae-bc4c-2fc5-e054-00144ff88e88
Set id: 1cba7bae-bc4b-2fc5-e054-00144ff88e88
Version: 1
Effective Time: 20150807
 
Pharma Associate Consultants, Inc