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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.

Presgen B

Drug Facts

Active Ingredients (in each 5 mL tsp)

Brompheniramine Maleate, 4 mg

Dextromethorphan HBr, 20 mg

Phenylephrine HCl, 10 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing, • itchy nose or throat, • runny nose • itchy, watery eyes • nasal congestion

• temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants.

• temporarily restores freer breathing through nose

Warnings

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 • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. Do not give this product to children who have breathing problems such as chronic bronchitis or who have glaucoma without first consulting child's doctor

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage. • may cause drowsiness • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness effect. • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever           • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in any 24-hour period

EVERY 4 HOURS  Adults and Children 12 years of age and over                  5mL (1 tsp)
 Children 6 years to under 12 years                                   2. 5 mL (1/2 tsp)
 Children under 6 years                                                     consult physician
 Children under 2 years                                                     do not use

Other information

• Tamper evident feature: Do not use if inner seal is torn, broken or missing.
• Store at controlled room temperature 15-30°C (59-86°F).
• Avoid excessive heat or humidity.

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

Compare to Tussi- Pres B®

Brompheniramine Maleate

ANTIHISTAMINE

Dextromethorphan HBr

COUGH SUPPRESSANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARINE FREE

DYE FREE

GRAPE FLAVOR

Manufactured in the USA for Kramer Novis. San Juan, PR 00917

Tel: (787) 767-2072. www.kramernovis.com

Packaging

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
CITRIC ACID MONOHYDRATE 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE, UNSPECIFIED FORM 
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)

 
KRAMER NOVIS

Medically reviewed on Dec 4, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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