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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

NDC Product Code24286-1565
Application NumberM012
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic NameDIPHENHYDRAMINE HYDROCHLORIDE

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