TUSSI PRES B- dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup

Tussi Pres B by

Drug Labeling and Warnings

Tussi Pres 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 Ingredients (in each 5 mL tsp)

Brompheniramine Maleate, 4 mg

Dextromethorphan HBr, 20 mg

Phenylephrine HCl, 10 mg

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 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, 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 the 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:

if you get nervous, dizzy or sleepless  new symptoms occur  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 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 (1tsp)
	Children 6 years to under 12 years            2.5mL (1/2 tsp)
	Children under 6 years                           consult physician
	Children under 2 years                                 do not use

OTHER SAFETY INFORMATION

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 excess heat or humidity

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

Brompheniramine Maleate
ANTIHISTAMINE

Dextromethorphan HBr
COUGH SUPPRESSANT

Phenylephrine HCl
NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARIN 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

TUSSI PRES B 
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-237
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: 52083-237-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2011
2	NDC: 52083-237-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2011
3	NDC: 52083-237-16	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)