BIO T PRES-B- brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Bio T Pres-B by

Drug Labeling and Warnings

Bio T Pres-B by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL tsp)             Purpose

Brompheniramine maleate 1 mg                                Antihistamine

Dextromethorphan HBr 5 mg                                  Cough Suppressant 

Phenylephrine HCl 2.5 mg                                      Nasal Decongestant

PURPOSE

Uses

•  temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
• • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, water 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 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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not use on a child under 2 years of age.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• glaucoma
• diabetes
• 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

Ask a doctor or a pharmacist before

• giving this product to children who are taking sedatives or tranquilizers
• if you are taking sedatives or tranquilizers
  

DO NOT USE

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

When using this product

• do not use more than directed
• may cause drowsiness
• avoid alcoholic drink
• 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 sleeplessness
• 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 a serious condition.
  

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions Do not exceed more than 6 doses in any 24-hour period.

• adults and children 12 years of age and over: take 1 teaspoonfuls (5 mL) every 4 hours
• children 6 to under 12 years of age: take 1/2 teaspoonfuls (2.5mL) every 4 hours
• children 2 years to under 6 years of age: ask a doctor
• children under 2 years of age: do not use

INDICATIONS & USAGE

Other Information

• Store between 15-30 degrees C (59-89 degrees F)
• Tamper evident feature: Do not use if cap seal is broken or missing

INACTIVE INGREDIENT

Inactive Ingredients

Water, citric acid, methylparaben, glycerin, propylene glycol, propylparaben, sodium citrate, flavor, sucralose

QUESTIONS

Questions or comments: 1-305-403-3788

Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO T PRES-B 
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-226
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-226-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2012

Labeler - Advanced Generic Corporation (831762971)