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Bactimicina Childrens Cough and Cold

Bactimicina Liquid Children's Cough and Cold

Approved
Approval ID

d407a583-07ae-4d47-b15a-24b5865c82da

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

DLC Laboratories, Inc.

DUNS: 093351930

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24286-1551
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (10)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CHLORPHENIRAMINE MALEATEActive
Quantity: 1 mg in 5 mL
Code: V1Q0O9OJ9Z
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 7.5 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/31/2022

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

Bactimicina Children CC 2025

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/22/2021

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 - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/22/2021

Active ingredients (in each 5 mL = 1 teaspoon)

Purposes

Chlorpheniramine maleate, USP 1 mg

Antihistamine

Dextromethorphan HBr, USP 7.5 mg

Cough suppressant

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/22/2021

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

WARNINGS SECTION

LOINC: 34071-1Updated: 10/22/2021

Warnings

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

Ask a doctor or pharmacist before use if you aretaking 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

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.

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

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/22/2021

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/22/2021

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 10/22/2021

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/22/2021

Questions

1-800-858-3889

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Bactimicina Childrens Cough and Cold - FDA Drug Approval Details