Major 44-015-dsp

Major 44-015-dsp
SPL v5
SPL
SPL Set ID fa12a5a8-bf2d-4991-9d54-9c519e8e04cd
Route
ORAL
Published
Effective Date 2024-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucrose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-27
Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

How Supplied

Product: 50090-6541 NDC: 50090-6541-0 118 mL in a BOTTLE, PLASTIC

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-6541

NDC: 50090-6541-0 118 mL in a BOTTLE, PLASTIC

Description

Diphenhydramine HCl 12.5 mg

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
Directions
  • do not take more than directed
  • do not take more than 6 doses in 24 hours
  • mL = milliliter
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
Age Dose
adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 years do not use unless directed by a doctor
children under 2 years do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each teaspoonful (5 mL) contains: sodium 4 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions Or Comments?

1- 800-426-9391

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
Diphenhydramine Hcl Solution
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 right away.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Active Ingredient (in Each Teaspoonful (5 Ml))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

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
Purpose

Antihistamine

Directions
  • do not take more than directed
  • do not take more than 6 doses in 24 hours
  • mL = milliliter
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
Age Dose
adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 years do not use unless directed by a doctor
children under 2 years 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
How Supplied (HOW SUPPLIED)

Product: 50090-6541

NDC: 50090-6541-0 118 mL in a BOTTLE, PLASTIC

Other Information (Other information)
  • each teaspoonful (5 mL) contains: sodium 4 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions Or Comments? (Questions or comments?)

1- 800-426-9391

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
Diphenhydramine Hcl Solution (DIPHENHYDRAMINE HCL solution)
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Active Ingredient (in Each Teaspoonful (5 Ml)) (Active ingredient (in each teaspoonful (5 mL)))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:39.823626 · Updated: 2026-03-14T23:02:20.876891