Diphenhydramine Hcl

Diphenhydramine Hcl
SPL v2
SPL
SPL Set ID 1db57d86-39f0-f8ca-e063-6394a90a6397
Route
ORAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Water Noncrystallizing Sorbitol Solution Propylene Glycol Sucralose Citric Acid Potassium Citrate Methylparaben Propylparaben Ammonium Glycyrrhizinate Trihydrate Cherry

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-20
Description

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

Medication Information

Warnings and Precautions

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.

Indications and 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

Dosage and 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

Description

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

Section 50565-1

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.

Section 51727-6

Inactive Ingredients: Citric Acid,

Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol,

Propylparaben, Purified Water, Sorbitol, Sucralose

Section 55105-1

Purpose: Antihistamine

Section 55106-9

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Drug Facts

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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 and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Inactive Ingredients: Citric Acid,

Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol,

Propylparaben, Purified Water, Sorbitol, Sucralose

Section 55105-1 (55105-1)

Purpose: Antihistamine

Section 55106-9 (55106-9)

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Drug Facts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.840760 · Updated: 2026-03-14T23:08:57.795400