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Presgen B

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL, BROMPHENIRAMINE MALEATE 4mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: KRAMER NOVIS
NDC Code: 52083-637

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.

DRUG FACTS

Active Ingredients/5 ml: brompheniramine maleate 4 mg, dextromethorphan hydrobromide 20 m, phenylephrine hydrochloride 10 mg

Decongestant, antihistamine, antitussive (anti cough)

:  relieves nasal congestion associated with sinusitis. relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. relieves sinus congestion and pressure ,helps decongest sinus openings and passages. restores free breathing. suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergie

WarningsA 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 fever, rash, or persistent headache, consult a doctor

Do not:Use more than the recommended dose. Give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor
May cause excitability especially in children
Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
May cause drowsiness: alcohol, sedatives, and tranquilizers may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.  Use caution when driving a motor vehicle or operating machinery
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
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)
In case of accidental overdose, contact a Poison Control center immediately
Prompt medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.

Keep this and all medicines out of the reach of children

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product

Inactives: Citric Acid, Flavor, Glycerin, Methylparaben, propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose

MM1

Adults and children 12 years of age and older-Take 1 teaspoons (5 ml) every 4 hours as needed, do not exceed 6 teaspoons in 24 hours, or as directed by a doctor

Children 6-12 years, Take 1/2 teaspoon (2.5 ml) every 4 hours as needed, do not exceed 3 teaspoons in 24 hours, or as directed by a doctor

Children under 6 years, consult a physician

PRESGEN B  
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-637
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE 
METHYLPARABEN 
PROPYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (SWEET GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-637-16480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/29/2011
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(52083-637)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(52083-637)

Revised: 01/2013
 
KRAMER NOVIS

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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