Major 44-015-dsp

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 2022-10-14

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Uses

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

Directions

•
do not take more than 6 doses in 24 hours
•
mL = milliliter; FL OZ = fluid ounce
•
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 5 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, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions Or Comments?

(800) 616-2471

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

MAJOR®

NDC 68788-8274-1

Relabeled By: Preferred Pharmaceuticals Inc.

Diphenhydramine HCl

Oral Solution

Antihistamine

12.5 mg/5 mL

Institutional Dispensing only

Cherry Flavored

Alcohol Free

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV1019A01521

Distributed by: MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Rev. 03/21 M-17

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product

•
avoid alcoholic beverages
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
excitability may occur, especially in children
•
marked drowsiness may occur
•
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:
- o
  runny nose
- o
  sneezing
- o
  itchy, watery eyes
- o
  itching of the nose or throat

Purpose

Antihistamine

Directions

•
do not take more than 6 doses in 24 hours
•
mL = milliliter; FL OZ = fluid ounce
•
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 5 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, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions Or Comments? (Questions or comments?)

(800) 616-2471

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel (Principal display panel)

MAJOR®

NDC 68788-8274-1

Relabeled By: Preferred Pharmaceuticals Inc.

Diphenhydramine HCl

Oral Solution

Antihistamine

12.5 mg/5 mL

Institutional Dispensing only

Cherry Flavored

Alcohol Free

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV1019A01521

Distributed by: MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Rev. 03/21 M-17

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product (When using this product)

•
avoid alcoholic beverages
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
excitability may occur, especially in children
•
marked drowsiness may occur
•
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: o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat", "Purpose": "Antihistamine", "Directions": "• do not take more than 6 doses in 24 hours • mL = milliliter; FL OZ = fluid ounce • 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 5 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, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose", "Questions or comments?": "(800) 616-2471 Relabeled By: Preferred Pharmaceuticals Inc.", "Principal display panel": "MAJOR® NDC 68788-8274-1 Relabeled By: Preferred Pharmaceuticals Inc. Diphenhydramine HCl Oral Solution Antihistamine 12.5 mg/5 mL Institutional Dispensing only Cherry Flavored Alcohol Free TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV1019A01521 Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Rev. 03/21 M-17 Relabeled By: Preferred Pharmaceuticals Inc.", "When using this product": "• avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • marked drowsiness may occur • 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