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Name:Bio-b Kids
Manufacturer:Advanced Generic Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BIO-B KIDS  - dextromethorphan hydrobromide, chlorpheniramine maleate and phenylephrine hydrochloride liquid 
Advanced Generic Corporation

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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Drug Facts

Active Ingredients: (in each 5 mL tsp.)              Purpose

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

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

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


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

  • 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.


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.In case of overdose, get medical help or contact a Poison Control Center right away.

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

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

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

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

BioBKidsLabel


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
Water  
Methylparaben  
Propylparaben  
Propylene Glycol  
Sodium Citrate  
Saccharin Sodium  
GLYCERIN  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (Strawberry Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45737-218-16 473 mL in 1 BOTTLE None

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)

Revised: 03/2011 Advanced Generic Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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