DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid 
Precision Dose, Inc.

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Dye Free Children's Diphenhydramine Hydrochloride

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

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

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

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 (1-800-222-1222) right away.

Directions

  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • mL = milliliter
  • find the right dose on the chart below
Age (yr)Dose (mL)
children 6 to 11 years5 mL to 10 mL
children 2 to 5 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use

Other information

  • each 5 mL contains: sodium 8 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light.

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Alcohol Free, Dye Free

How Supplied

NDC 68094-022-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-022-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-024-62
10 mL per unit dose cup
Thirty (30) cups per shipper

Manufactured by:
PL Developments
Lynwood, CA 90262

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1156 Rev. 04/22

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-022-59

PrecisionDose™

Children's DYE FREE
diphenhydrAMINE HCl Liquid
12.5 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-022(NDC:49580-0293)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-022-623 in 1 CASE12/27/201811/30/2024
110 in 1 TRAY
1NDC:68094-022-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01212/27/201811/30/2024
Labeler - Precision Dose, Inc. (035886746)

Revised: 1/2024
Document Id: b00aa04e-8c8f-4da5-9f36-e086e9c84c28
Set id: 139f7be5-c361-492c-ba3a-573ced661857
Version: 4
Effective Time: 20240112
 
Precision Dose, Inc.