GUAIFENESIN PHENYLEPHRINE DEXTROMETHORPHAN   - guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, coated 
Kramer Novis.

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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Active Ingredients (In Each Tablet)                       
Guaifenesein    400 mg
Phenylephrine HCl 10 mg
Dextromethorphan HBr. 20 mg

Expectorant, nasal decongestant, antitussive (anti cough)

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

Directions:
Adults and children 12 years of age and older
•    Take 1 tablet every 4 hours as needed, do not exceed 6  
tablets in 24 hours, or as directed by a doctor.
•    Children under 12 years, consult a doctor
•    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 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 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)

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 for  
children even if you do not notice any signs or symptoms.

Inactive Ingredients: Hypromellose,  Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol,  Povidone,  Sodium Starch Glycolate, Stearic Acid

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GUAIFENESIN PHENYLEPHRINE DEXTROMETHORPHAN  
guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-249
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
PROPYLENE GLYCOL 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
Colorwhite (snow white) Score2 pieces
ShapeCAPSULE (T) Size19mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52083-249-022 TABLET, COATED ( TABLET) in 1 PACKETNone
2NDC:52083-249-6060 TABLET, COATED ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/18/2012

Labeler - Kramer Novis. (090158395)
Registrant - Ultraseal Corporation (085752004)
Establishment
NameAddressID/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture

Revised: 08/2012 Kramer Novis.