Bactimicina Liquid Children's Cough And Cold

Bactimicina Liquid Children's Cough And Cold
SPL v9
SPL
SPL Set ID d407a583-07ae-4d47-b15a-24b5865c82da
Route
ORAL
Published
Effective Date 2022-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (1 mg) Dextromethorphan (7.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Glycerin

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-10-23

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 43683-2

ml=mililiter; tsp=teaspoonful

Section 50565-1

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

Section 50566-9

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.

Section 50568-5

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

Section 50570-1

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.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 5 mL = 1 teaspoon) Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant
Questions

1-800-858-3889

Directions
  • do not take more than 4 doses in any 24-hour period
  • mL=mililiter; tsp=teaspoonful
Age (years) Dose
Under 6 do not use
6-11 2 teaspoons (10 mL) every 6 hours
12 and over 4 teaspoons (20 mL) every 6 hours
Other Information
  • each teaspoon (5 mL) contains: sodium 1 mg
  • store at 15-30°C (59-86°F)
  • measure only with dosage cup provided
  • do not use if printed bottle wrap is missing or broken.
Inactive Ingredients

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

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
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
Principal Display Panel 118 Ml Bottle Label

Long Acting

Voltee Para

Espanol

TRUSTED SINCE 1978

Children's

Bactimicina®

Ages 6+ Years

Milti-Symptom • Liquid

Cough & Cold

Dextromethorphan HBr (Cough Suppressant)

Chlorpheniramine Maleate (Antihistamine)

Relieves Cough up to 8hrs

Sneezing • Runny Nose

Alcohol Free• Sugar Free

Natural Strawberry Flavor

4 FL OZ (118 mL) Dosing Cup Included


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

ml=mililiter; tsp=teaspoonful

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL = 1 teaspoon) Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant
Questions

1-800-858-3889

Directions
  • do not take more than 4 doses in any 24-hour period
  • mL=mililiter; tsp=teaspoonful
Age (years) Dose
Under 6 do not use
6-11 2 teaspoons (10 mL) every 6 hours
12 and over 4 teaspoons (20 mL) every 6 hours
Other Information (Other information)
  • each teaspoon (5 mL) contains: sodium 1 mg
  • store at 15-30°C (59-86°F)
  • measure only with dosage cup provided
  • do not use if printed bottle wrap is missing or broken.
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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
Ask A Doctor Before Use If You Have (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
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

Long Acting

Voltee Para

Espanol

TRUSTED SINCE 1978

Children's

Bactimicina®

Ages 6+ Years

Milti-Symptom • Liquid

Cough & Cold

Dextromethorphan HBr (Cough Suppressant)

Chlorpheniramine Maleate (Antihistamine)

Relieves Cough up to 8hrs

Sneezing • Runny Nose

Alcohol Free• Sugar Free

Natural Strawberry Flavor

4 FL OZ (118 mL) Dosing Cup Included


Advanced Ingredient Data


Raw Label Data

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