BACTIMICINA CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

BACTIMICINA CHILDRENS ALLERGY by

Drug Labeling and Warnings

BACTIMICINA CHILDRENS ALLERGY by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

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

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.

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.

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 ingredients

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

Questions

1-800-858-3889

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

LIQUID
BACTIMICINA®

Diphenhydramine HCl / Antihistamine

Children's
Allergy

Ages 6 & Over

Relieves:

• RUNNY NOSE
• SNEEZING
• ITCHY, WATERY EYES
• ITCHY THROAT

Alcohol Free

Cherry Flavor

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

BACTIMICINA CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1565
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1565-4	1 in 1 CARTON	06/17/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/17/2015

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Business Operations
DLC Laboratories, Inc.		093351930	MANUFACTURE(24286-1565) , LABEL(24286-1565)