DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid 
Precision Dose, Inc.
Reference Label Set Id: 139f7be5-c361-492c-ba3a-573ced661857

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Dye Free Children's Diphenhydramine HCl Liquid

Drug Facts

Active ingredient (in each 5 mL )

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

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

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

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

Manufactured by:
PL Developments
Lynwood, CA 90262

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

LI1156 Rev. 04/22

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

NDC 68094-024-59

PrecisionDose™

Children's DYE FREE
diphenhydrAMINE HCl Liquid
25 mg/10 mL

Delivers 10 mL, each 5 mL contains: sodium 8 mg
Alcohol Free, Protect from light, Hospital Use Only

Store between 20°-25°C (68°-77°F)
Do not refrigerate
Pkg. By: Precision Dose, Inc.
South Beloit, IL 61080
1158 R0

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
DYE FREE CHILDRENS DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-024(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:68094-024-623 in 1 CASE12/27/201810/31/2024
110 in 1 TRAY
1NDC:68094-024-5910 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 drugM01212/27/201810/31/2024
Labeler - Precision Dose, Inc. (035886746)

Revised: 1/2024
Document Id: a901bbfd-3f1c-47bb-8abb-83b3661fed78
Set id: 0b944f09-9317-446d-951a-4a7b75a8af1e
Version: 2
Effective Time: 20240112
 
Precision Dose, Inc.