PRESGEN B - dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup 
KRAMER NOVIS

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.

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PRESGEN® B

Drug Facts

Active Ingredients (in each 5 mL tsp)

Brompheniramine Maleate, 4 mg
Dextromethorphan HBr, 20 mg
Phenylephrine HCl, 10 mg

Purposes

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.

While using this product:
• do not exceed recommended dosage • excitability may occur especially in children • drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

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 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: 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, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water 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, Puerto Rico 00917 Tel.787-767-2072 www.kramernovis.com

Packaging

Label

PRESGEN B  
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-637
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (SWEET GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-637-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2011
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)

Revised: 10/2019
Document Id: 8d67304c-5718-4e3f-be6b-b5d920f442b2
Set id: 5befa829-32bd-4978-8a0e-1d6513ff37a4
Version: 4
Effective Time: 20191031
 
KRAMER NOVIS