DIPHENHYDRAMINE HCL- diphenhydramine hcl solution 
Belleview Biosciences

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Diphenhydramine HCL

Directions: Take every 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose

AgeDose
Adults and Children 12 years of age and overtake 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours
Children 6 to under 12 years of agetake 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
Children under 6 years of ageConsult a doctor

Warnings:

Do not use: ■ with any other product containing

diphenhydramine, even one used on skin ■ to make a

child sleepy

Ask a doctor before use if you have: ■ a breathing

problem such as emphysema or chronic bronchitis

■ glaucoma ■ trouble urinating due to the enlarged

prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product: ■ excitability might occur,

especially in children ■ marked drowsiness may occur

■ avoid alcoholic drinks ■ alcohol, sedatives, and

tranquilizers may increase drowsiness effect ■ be careful

when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health

professional before use.

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.

Inactive Ingredients: Citric Acid,

Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol,

Propylparaben, Purified Water, Sorbitol, Sucralose

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 ■ Temporarily relieves

these symptoms due to the common cold: ■ runny

nose ■ sneezing

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.

Purpose: Antihistamine

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Drug Facts

Bulk Label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84447-103
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
WATER (UNII: 059QF0KO0R)  
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID (UNII: 2968PHW8QP)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
AMMONIUM GLYCYRRHIZINATE TRIHYDRATE (UNII: 78NEL3149I)  
CHERRY (UNII: BUC5I9595W)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84447-103-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2024
2NDC:84447-103-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2024
3NDC:84447-103-01200000 mL in 1 DRUM; Type 0: Not a Combination Product07/20/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/20/2024
Labeler - Belleview Biosciences (131968803)

Revised: 6/2025
Document Id: 3765beab-e853-b34f-e063-6394a90ac9d5
Set id: 1db57d86-39f0-f8ca-e063-6394a90a6397
Version: 2
Effective Time: 20250612
 
Belleview Biosciences