Diphenhydramine Hcl Oral Solution 25 Mg/10 Ml

Diphenhydramine Hcl Oral Solution 25 Mg/10 Ml
SPL v3
SPL
SPL Set ID 8f0ba9e5-a31d-4d77-8155-c16c7e74edef
Route
ORAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Methylparaben Propylene Glycol Propylparaben Sodium Citrate Sucralose Water

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-15
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

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

Section 51727-6

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

Section 53413-1

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

Directions

• take every 4 to 6 hours, or as directed by a physician

• do not take more than 6 doses in 24 hours

age dose
Adults and children over 12 years of age 10 mL (25 mg) to 20 mL (50 mg)
Children 6 to under 12 years of age 10 mL (25 mg)
Children under 6 years of age Do not use

Do Not Use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

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

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

Principal Display Panel

25 mg/10 mL

Case Label NDC 57237-318-11

Lid Label NDC 57237-318-01

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

Ask A Doctor Before Use If You Have

• a breathing problem such as chronic bronchitis

• glaucoma

• trouble urinating due to enlarged prostate gland

Active Ingredient Per 10 Ml (1 Unit Dose)

Diphenhydramine HCl 25 mg

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

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

Purpose

Antihistamine

Directions

• take every 4 to 6 hours, or as directed by a physician

• do not take more than 6 doses in 24 hours

age dose
Adults and children over 12 years of age 10 mL (25 mg) to 20 mL (50 mg)
Children 6 to under 12 years of age 10 mL (25 mg)
Children under 6 years of age Do not use

Do Not Use (Do not use)

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

Ndc Information (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

Other Information (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

25 mg/10 mL

Case Label NDC 57237-318-11

Lid Label NDC 57237-318-01

When Using This Product (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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• a breathing problem such as chronic bronchitis

• glaucoma

• trouble urinating due to enlarged prostate gland

Active Ingredient Per 10 Ml (1 Unit Dose) (Active ingredient per 10 mL (1 Unit Dose))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.071098 · Updated: 2026-03-14T23:09:16.713853