DIPHENHYDRAMINE HCL solution

Diphenhydramine HCL by

Drug Labeling and Warnings

Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by Belleview Biosciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

• Age: Dose
• Adults and Children 12 years of age and over: take 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours
• Children 6 to under 12 years of age: take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
• Children under 6 years of age: Consult a doctor

WARNINGS

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 INGREDIENT

Inactive Ingredients: Citric Acid,

Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol,

Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE

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

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

Purpose: Antihistamine

ACTIVE INGREDIENT

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Drug Facts

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84447-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84447-103-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2024
2	NDC: 84447-103-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2024
3	NDC: 84447-103-01	200000 mL in 1 DRUM; Type 0: Not a Combination Product	07/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/20/2024

Labeler - Belleview Biosciences (131968803)