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Presgen

Kramer Novis
Kramer Novis

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients per 5 ml: Guaifenesin 200 mg, Phenylephrine HCL 5 mg, Dextromethorphan HBr 10 mg

Purpose

COUGH SUPPRESSANT

NASAL DECONGESTANT

EXPECTORANT

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

temporarily relieves these symptoms occurring with cold:

nasal congestion

cough due to minor throat and bronchial irritation

Do Not Use: in a child under 2 years of age

if you are 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 the MAOI drug. If you do not know if

your prescription drug contains an MAOI, ask a doctor or pharmacist before

taking this product. 

Ask a doctor before use if you have heart disease, thyroid disease, high blood pressure, diabetes

trouble urinating due to enlargement of the prostate gland

cough that occurs with too much phlegm (mucus)

chronic bronchitis or emphysema

When using this product, do not exceed recommended dosage

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless

symptoms do not get better within 7 days or are accompanied by fever

cough lasts more than 7 days, comes back, or is accompanied by fever,

rash, or persistent headache. These could be signs of a serious condition

adults and children 12 years and over 10mL (2 tsp) every 4 hours

children 6 to under 12 years 5mL (1 tsp) every 4 hours

children 2 to under 6 years 2.5mL (1/2 tsp) every 4 hours

under 2 years do not use

do not take more than 6 doses in any 4 hour period

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

Keep out of reach of children

Inactive Ingredients:

citric acid,red 40,glycerin,methylparaben,potassium sorbate,propylene glycol,propylparaben,purified water,sodium citrate,sucralose

MM1Presgen

Presgen

guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52083-632(NDC:62959-100)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg

Inactive Ingredients

Ingredient Name Strength
water
CITRIC ACID MONOHYDRATE
GLYCERIN
SODIUM CITRATE
METHYLPARABEN
PROPYLPARABEN
Sucralose
POTASSIUM SORBATE

Product Characteristics

Color
red (CHERRY RED)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-632-16 480 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-03-28


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Be sure to consult your doctor before taking any medication!
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