Diphenhydramine Hcl Oral Solution 12.5 Mg/5 Ml

Diphenhydramine Hcl Oral Solution 12.5 Mg/5 Ml
SPL v3
SPL
SPL Set ID 0f9015c9-a95a-5703-e063-6394a90a6ad2
Route
ORAL
Published
Effective Date 2025-09-04
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 Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-01-22 Until 2026-07-31
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 istaking 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? (855) 879-4368

Directions

For the 10 mL Unit-Dose:

• 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 6 years of age

                   Do not use

Children 6 to under 12 years of age

               10 mL (25 mg)

Adults and children 12 years of age and over

 10 mL (25 mg) to 20 mL (50 mg) 
Do Not Use

• to make a child sleepy

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

Directions 

For the 5 mL Unit-Dose: 

• 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)
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

MAJOR®

NDC 0904-7323-41

Each 5 mL Contains:

Diphenhydramine HCL Oral Solution 

12.5 mg/5 mL

Antihistamine

Delivers 5 mL • See insert

For Institutional Use Only

Cherry Flavor 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Sugar Free • Alcohol Free

When Using This Product

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

Active Ingredient Per 5 Ml (1 Unit Dose)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has

• a breathing problem such as chronic bronchitis

• glaucoma

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 the child istaking 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? (855) 879-4368

Purpose

Antihistamine

Directions

For the 10 mL Unit-Dose:

• 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 6 years of age

                   Do not use

Children 6 to under 12 years of age

               10 mL (25 mg)

Adults and children 12 years of age and over

 10 mL (25 mg) to 20 mL (50 mg) 
Do Not Use (Do not use)

• to make a child sleepy

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

Directions 

For the 5 mL Unit-Dose: 

• 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)
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)

MAJOR®

NDC 0904-7323-41

Each 5 mL Contains:

Diphenhydramine HCL Oral Solution 

12.5 mg/5 mL

Antihistamine

Delivers 5 mL • See insert

For Institutional Use Only

Cherry Flavor 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Sugar Free • Alcohol Free

When Using This Product (When using this product)

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

Active Ingredient Per 5 Ml (1 Unit Dose) (Active ingredient per 5 mL (1 Unit Dose))

Diphenhydramine HCl 12.5 mg

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

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: 2026-02-15T12:06:55.479394 · Updated: 2026-03-14T23:09:59.416921