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

Presgen B by

Drug Labeling and Warnings

Presgen B by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL tsp)

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

PURPOSE

Purposes

Antihistamine
Cough Suppressant
Nasal Decongestant

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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 INGREDIENT

Inactive ingredients: Citric acid, flavor, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water and sucralose

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PRESGEN B  
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-637
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE (SWEET GRAPE)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-637-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/29/2011

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)