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BACTIMICINA CHILDRENS ALLERGY

BACTIMICINA CHILDREN'S ALLERGY

Approved
Approval ID

eaf554d4-a758-4ed6-bec5-d6cbfedae408

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.

DIPHENHYDRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24286-1565
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (11)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 5 mL
Code: TC2D6JAD40
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/3/2022

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

4-6 Hour Relief

Voltee Para

Español

TRUSTED SINCE 1978

Children's

Bactimicina®

Ages 6+ Years

Antihistamine • Liquid

Allergy

Diphenhydramine HCL (Antihistamine)

Sneezing • Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Alcohol Free

Cherry Flavor

4 FL OZ (118 mL) Dosing Cup Included

Bactimicina Children Allergy

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/14/2018

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/14/2018

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/14/2018

Active ingredient (in each 5 mL = 1 teaspoonful)

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/14/2018

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 11/14/2018

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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: 11/14/2018

Directions

  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter; tsp = teaspoonful

Age (yr)

Dose (mL or tsp)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL (1 tsp) to 10 mL (2 tsp)

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 11/14/2018

Other information

*each 5 mL (1 tsp) contains: sodium 2.3 mg

  • store at room temperature. Protect from light. Store in outer carton until contents used.
  • dosage cup provided *do not use if printed bottle wrap is missing or broken

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/14/2018

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/14/2018

Questions

1-800-858-3889

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BACTIMICINA CHILDRENS ALLERGY - FDA Drug Approval Details