BIO-B KIDS- dextromethorphan,chlorpheniramine maleate, phenylephrine liquid

Bio-B Kids by

Drug Labeling and Warnings

Bio-B Kids 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

Chlorpheniramine Maleate 4 mg................................Antihistamine

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Phenylephrine HCl 10 mg.................................. Decongestant

PURPOSE

Uses

• temporarily relieves these symptoms due to cold, hay fever or other upper respiratory allergies
• runny nose, sneezing, itching of the nose or throat, and itchy watery eyes
• cough due to minor throat and bronchial irritation
• nasal congestion
  

WARNINGS

Warnings

• ask your doctor before use if you have
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• glaucoma
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Warning 

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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

DO NOT USE

Stop Use and ask a doctor if

• You get nervous, dizzy or sleepless
• symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

When using this product

• do not exceed recommended dosage
• may cause excitability especially in children
• may cause drowsiness, alcohol, sedatives, tranquilizers may increase the drowsiness effect
• avoid alcoholic beverage while taking this product
• use caution when driving a motor vehicle or operating machinery
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.In case of 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 6 doses in 24 hours.

adults and children 12 years of age and over take 1 teaspoonful (5 mL) every 4 to 6 hours

children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 4 to 6 hours

children under 6 years of age  consult a doctor

INDICATIONS & USAGE

Other information  store at room temperature 15°- 30°C (59° - 86°F). Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering

Tamper Evident Feature: Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

QUESTIONS

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

INACTIVE INGREDIENT

Inactive ingredients Glycerin, propylene glycol, methylparaben, propylparaben, saccharin sodium, citric acid, sodium citrate, FD and C Red No. 40, strawberry flavor and purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO-B KIDS 
dextromethorphan,chlorpheniramine maleate, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-218
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	15 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE 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)
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (Strawberry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-218-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2009

Labeler - Advanced Generic Corporation (831762971)