Diphenhydramine Hcl Oral Solution 12.5 Mg/5 Ml

Diphenhydramine Hcl Oral Solution 12.5 Mg/5 Ml
SPL v3
SPL
SPL Set ID 7406e4e4-3093-4cd1-80ce-93f7b6db2a87
Route
ORAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 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 the child is 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

Section 55106-9

Diphenhydramine HCl 12.5 mg

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
Children under 2 years of age Do not use
Children 2 to under 6 years of age Do not use unless directed by a doctor
Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)

Do Not Use

• to make a child sleepy

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

Ndc Information

12.5 mg/5 mL

Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms:

NDC 57237-317-05: 5 mL unit dose cup

NDC 57237-317-51: 100 x 5 mL Unit-Dose Cups

Other Information

• each 5 mL contains sodium: 3 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

12.5 mg/5 mL

Case Label NDC 57237-317-51

Lid Label NDC 57237-317-05

When Using This Product

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

Ask A Doctor Before Use If the Child Has

• a breathing problem such as chronic bronchitis

• glaucoma

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 the child is 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

Section 55106-9 (55106-9)

Diphenhydramine HCl 12.5 mg

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
Children under 2 years of age Do not use
Children 2 to under 6 years of age Do not use unless directed by a doctor
Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)

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 -)

12.5 mg/5 mL

Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms:

NDC 57237-317-05: 5 mL unit dose cup

NDC 57237-317-51: 100 x 5 mL Unit-Dose Cups

Other Information (Other information)

• each 5 mL contains sodium: 3 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)

12.5 mg/5 mL

Case Label NDC 57237-317-51

Lid Label NDC 57237-317-05

When Using This Product (When using this product)

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

• a breathing problem such as chronic bronchitis

• glaucoma

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.056117 · Updated: 2026-03-14T23:09:16.713853