DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride solution 
PAI Holdings, LLC

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Diphenydramine HCl Oral Solution, USP

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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. (1-800-222-1222)

Directions

Age (yr) Dose (mL)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years5 mL to 10 mL

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

Other information

Inactive ingredients

citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.

Questions or comments?

Call 1-800-845-8210

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0865-05

Diphenydramine HCl Oral Solution USP

12.5 mg/5 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

Principal Display Panel

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1730-10

Diphenydramine HCl Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Package Not Child-Resistant

Principal Display Panel
DIPHENHYDRAMINE HCL 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0865
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorwhite (CLEAR) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0865-0010 in 1 CASE06/18/2020
110 in 1 TRAY
1NDC:0121-0865-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:0121-0865-303 in 1 CASE06/18/2020
210 in 1 TRAY
2NDC:0121-0865-055 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 DrugM01206/18/2020
DIPHENHYDRAMINE HCL 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1730
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorwhite (CLEAR) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1730-0010 in 1 CASE06/18/2020
110 in 1 TRAY
1NDC:0121-1730-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:0121-1730-303 in 1 CASE06/18/2020
210 in 1 TRAY
2NDC:0121-1730-1010 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 DrugM01206/18/2020
Labeler - PAI Holdings, LLC (044940096)
Establishment
NameAddressID/FEIBusiness Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-0865, 0121-1730)

Revised: 1/2024
Document Id: 03896fcb-b584-4556-9cb9-d2ce819e4ca8
Set id: 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc
Version: 4
Effective Time: 20240105
 
PAI Holdings, LLC