FDA Label for Bactimicina Childrens Cough And Cold

View Indications, Usage & Precautions

Bactimicina Childrens Cough And Cold Product Label

The following document was submitted to the FDA by the labeler of this product Dlc Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Manufactured by:
DLC Laboratories, Inc.
Paramount, CA 90723 USA


Otc - Purpose



Active ingredients (in each 5 mL = 1 teaspoon)Purposes
Chlorpheniramine maleate, USP 1 mgAntihistamine
Dextromethorphan HBr, USP 7.5 mgCough suppressant

Uses



  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat

Otc - Do Not Use



Do not use

  • to sedate a child or to make a child sleepy
  • 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.

Ask A Doctor Before Use If You Have



  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist



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


When Using This Product



  • do not use more than directed 
  • marked drowsiness may occur 
  • avoid alcoholic drinks 
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • be careful when driving a motor vehicle or operating machinery          
  • excitability may occur, especially in children

Otc - Stop Use



Stop use and ask a doctor if 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.


Otc - Pregnancy Or Breast Feeding



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


Otc - 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.


Directions



  • do not take more than 4 doses in any 24-hour period
  • Age (years) Dose
    Under 6do not use
    6-112 teaspoons (10 mL) every 6 hours
    12 and over4 teaspoons (20 mL) every 6 hours

Other Information



  • each teaspoon (5 mL) contains: sodium 1 mg
  • store at 15-30°C (59-86°F)
  • dosage cup provided

Inactive Ingredients



citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose


Questions



1-800-858-3889


Principal Display Panel - 118 Ml Bottle Carton



LIQUID
BACTIMICINA
®

Chlorpheniramine Maleate /
Antihistamine

Dextromethorphan HBr /
Cough Suppressant

Children's
Cough
& Cold

Ages 6 & Over

  Relieves:
• COUGH: up to 8 hours
• SNEEZING
• RUNNY NOSE
• ITCHY, WATERY EYES

Alcohol Free
Long-Acting

Strawberry Flavor

4 FL OZ (118 mL)


* Please review the disclaimer below.