GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Dosage form: syrup
Ingredients: GUAIFENESIN 200mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL
Labeler: River’s Edge Pharmaceuticals, LLC
NDC Code: 68032-603

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.

Guaifenesin 200 mg/Phenylephrine Hydrochloride 5 mg per 5 mL

Active Ingredients (each 5 mL)

Guaifenesin 200 mg
Phenylephrine hydrochloride 5 mg

Purpose

Expectorant
Nasal Decongestant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive. Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis). Temporarily relieves nasal stuffiness. Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not use if you are now takin g 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.

If pregnant or breast-feeding,

ask a health professional before use.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance, or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and over: 10 mL every 4 hours, not to exceed 6 doses in 24 hours.
Children 6 to under 12 years of age: 5 mL every 4 hours, not to exceed 6 doses in 24 hours.
Children 2 to under 6 years of age: 2.5 mL every 4 hours, not to exceed 6 doses in 24 hours.
Children under 2 years of age: Consult a physician.

Other Information

Store at 20°-25°C (68°-77°F).

Inactive Ingredients

aspartame, bittermask, citric acid, glycerin, ethyl maltol, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, FD&C red #40, strawberry cream flavor, and sucrose.

Questions? Comments?

Call 1-866-934-6025

GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68032-603
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
ETHYL MALTOL 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
FD&C RED NO. 40 
SUCROSE 
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRY (strawberry-cream) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68032-603-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/08/201103/31/2013
Labeler - River’s Edge Pharmaceuticals, LLC (133879135)

Revised: 11/2011
 
River’s Edge Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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