Guaifenesin 200 mg/Phenylephrine Hydrochloride 5 mg per 5 mL

GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE  - guaifenesin and phenylephrine hydrochloride syrup 
River’s Edge Pharmaceuticals, LLC

----------

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

label

GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 
guaifenesin, phenylephrine hydrochloride   syrup
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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
#NDCPackage DescriptionMultilevel Packaging
168032-603-16473 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/08/2011

Labeler - River’s Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011River’s Edge Pharmaceuticals, LLC