Major 44-015 Delisted

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 Completed Since 2019-08-27 Until 2027-05-31

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- itching of the nose or throat
- runny nose
- sneezing
- itchy, watery eyes

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

Principal Display Panel

MAJOR®

NDC 0904-6985-16

Diphenhydramine HCl

Oral Solution

Antihistamine

12.5 mg/5 mL

Cherry Flavored

Ages 6 Years and Over

Institutional Dispensing Only

16 FL OZ (473 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0523B01521

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Rev. 07/23 M-17 Re-order No. 701181

Major 44-015

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

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
glaucoma
difficulty in urination due to enlargement of the prostate gland

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:
- itching of the nose or throat
- runny nose
- sneezing
- itchy, watery eyes

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

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

Principal Display Panel (Principal display panel)

MAJOR®

NDC 0904-6985-16

Diphenhydramine HCl

Oral Solution

Antihistamine

12.5 mg/5 mL

Cherry Flavored

Ages 6 Years and Over

Institutional Dispensing Only

16 FL OZ (473 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0523B01521

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Rev. 07/23 M-17 Re-order No. 701181

Major 44-015

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

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
glaucoma
difficulty in urination due to enlargement of the prostate gland

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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: itching of the nose or throat runny nose sneezing itchy, watery eyes", "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": "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", "Principal display panel": "MAJOR® NDC 0904-6985-16 Diphenhydramine HCl Oral Solution Antihistamine 12.5 mg/5 mL Cherry Flavored Ages 6 Years and Over Institutional Dispensing Only 16 FL OZ (473 mL) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0523B01521 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com Rev. 07/23 M-17 Re-order No. 701181 Major 44-015", "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", "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 glaucoma difficulty in urination due to enlargement of the prostate gland", "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information