Quality Plus 44-015

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 2024-06-28

Medication Information

Purpose

Antihistamine

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 6 doses in 24 hours
mL = milliliter; FL OZ = fluid ounce
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor

Age (yr)	Dose (mL)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 mL to 10 mL

Do Not Use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information

each 5 mL contains: sodium 5 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
protect from light

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?

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-015-19

Compare to active ingredient

in Children’s Benadryl® Allergy*

CHILDREN’S

ALLERGY

RELIEF

Diphenhydramine HCl 12.5 mg

Antihistamine

Relieves

• Sneezing

• Runny nose

• Itchy, Watery eyes

• Itchy throat

or nose

Cherry

Flavor

8 FL OZ (237 mL)

ALCOHOL FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Children’s Benadryl® Allergy.

50844 ORG051901519

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-015

When Using This Product

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has

glaucoma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If the Child Is

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 6 doses in 24 hours
mL = milliliter; FL OZ = fluid ounce
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor

Age (yr)	Dose (mL)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 mL to 10 mL

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 5 mL contains: sodium 5 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
protect from light

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?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QUALITY

+PLUS

NDC 50844-015-19

Compare to active ingredient

in Children’s Benadryl® Allergy*

CHILDREN’S

ALLERGY

RELIEF

Diphenhydramine HCl 12.5 mg

Antihistamine

Relieves

• Sneezing

• Runny nose

• Itchy, Watery eyes

• Itchy throat

or nose

Cherry

Flavor

8 FL OZ (237 mL)

ALCOHOL FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Children’s Benadryl® Allergy.

50844 ORG051901519

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-015

When Using This Product (When using this product)

marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

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.

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

Diphenhydramine HCl 12.5 mg

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

glaucoma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

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: runny nose sneezing itchy, watery eyes 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 use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. find right dose on chart below take every 4 to 6 hours, or as directed by a doctor Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "each 5 mL contains: sodium 5 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number protect from light", "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?": "1-800-426-9391", "Principal display panel": "QUALITY +PLUS NDC 50844-015-19 Compare to active ingredient in Children’s Benadryl® Allergy* CHILDREN’S ALLERGY RELIEF Diphenhydramine HCl 12.5 mg Antihistamine Relieves • Sneezing • Runny nose • Itchy, Watery eyes • Itchy throat or nose Cherry Flavor 8 FL OZ (237 mL) ALCOHOL FREE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Benadryl® Allergy. 50844 ORG051901519 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA Quality Plus 44-015", "When using this product": "marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each 5 mL)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor before use if the child has": "glaucoma a breathing problem such as chronic bronchitis", "Ask a doctor or pharmacist before use if the child is": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information