DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hcl oral solution 
Rising Pharma Holdings, Inc.

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Diphenhydramine HCl Oral Solution 25 mg/10 mL

Drug Facts

Active ingredient per 10 mL (1 Unit Dose)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

• Temporarily relieves these symptoms due to hay fever or other 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 you have

• a breathing problem such as chronic bronchitis
• glaucoma
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and traquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant or breast-feeding, ask a healthcare professional before use

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours

agedose
Adults and children over 12 years of age10 mL (25 mg) to 20 mL (50 mg)
Children 6 to under 12 years of age10 mL (25 mg)
Children under 6 years of ageDo not use

Other information

• each 10 mL contains sodium: 6 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken

Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? Call 1-844-474-7464

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

FG-36/Iss.:10/2023

NDC Information -

25 mg/10 mL

Each 10 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 25 mg and is supplied in the following oral dosage forms:

NDC 57237-318-01: 10 mL unit dose cup

NDC 57237-318-11: 100 x 10 mL Unit-Dose Cups

PRINCIPAL DISPLAY PANEL

25 mg/10 mL

Case Label NDC 57237-318-11

Diphenhydramine-Case-lab

Lid Label NDC 57237-318-01

Diphenhydramine-Lid-lab

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-318
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-318-11100 in 1 BOX, UNIT-DOSE12/15/2023
1NDC:57237-318-0110 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 DrugM009.5012/15/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 10/2024
Document Id: 2b443d28-977c-4d59-9f8c-36075af617b8
Set id: 8f0ba9e5-a31d-4d77-8155-c16c7e74edef
Version: 2
Effective Time: 20241017
 
Rising Pharma Holdings, Inc.