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

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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 Type HUMAN OTC DRUG NDC Product Code (Source) 68032-603 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ASPARTAME   CITRIC ACID MONOHYDRATE   GLYCERIN   ETHYL MALTOL   METHYLPARABEN   POTASSIUM CITRATE   POTASSIUM SORBATE   PROPYLENE GLYCOL   PROPYLPARABEN   WATER   FD&C RED NO. 40   SUCROSE

Product Characteristics Color red Score      Shape Size Flavor STRAWBERRY (strawberry-cream) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-603-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/08/2011

Labeler - River’s Edge Pharmaceuticals, LLC (133879135)

Revised: 04/2011River’s Edge Pharmaceuticals, LLC