TUSSI PRES 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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TUSSI PRES- 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 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.

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

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

image description

TUSSI PRES B 
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-237
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:52083-237-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2011
2NDC:52083-237-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2011
3NDC:52083-237-16480 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: be1c412d-21bb-4a19-b682-50d00fd3dccf
Set id: d0afa44c-3acf-42a5-9889-4e9c10225256
Version: 4
Effective Time: 20191029
 
KRAMER NOVIS