Cvs 44-669-delisted

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Starch, Corn Dextrose Monohydrate Ethylcellulose, Unspecified Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Maltodextrin Mannitol Stearic Acid Sucralose Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 44;669 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2015-03-20 Until 2027-06-30

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

Directions

find right dose on chart below
chew or crush tablets completely before swallowing; do not swallow tablets whole
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

Age (yr)	Dose (chewable tablets)
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	1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over	2 to 4 chewable tablets (25 mg to 50 mg)

Do Not Use

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

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid high humidity
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, maltodextrin, mannitol, stearic acid, sucralose, triacetin

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥CVS

Health_®

Compare to the active ingredient in

Children’s Benadryl^® Chewables*

Chewable Tablets

Children's

Allergy Relief

DIPHENHYDRAMINE

HYDROCHLORIDE, 12.5 mg

CHEWABLE TABLETS

Antihistamine

Relief of:

• Sneezing • Itchy, watery eyes

• Runny nose • Itchy throat

DYE

FREE

Actual Size

Bubble Gum Flavored

Child-Resistant Packaging

18 CHEWABLE TABLETS

Chew or crush tablets completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Children’s Benadryl^® Chewables.

50844 REV1218C66944

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com^® 1-800-SHOP CVS

√ CVS^® Quality

Money Back Guarantee

CVS 44-669

When Using This Product

avoid alcoholic beverages
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Chewable Tablet)

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

Purpose

Antihistamine

Directions

find right dose on chart below
chew or crush tablets completely before swallowing; do not swallow tablets whole
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

Age (yr)	Dose (chewable tablets)
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	1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over	2 to 4 chewable tablets (25 mg to 50 mg)

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)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid high humidity
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, maltodextrin, mannitol, stearic acid, sucralose, triacetin

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥CVS

Health_®

Compare to the active ingredient in

Children’s Benadryl^® Chewables*

Chewable Tablets

Children's

Allergy Relief

DIPHENHYDRAMINE

HYDROCHLORIDE, 12.5 mg

CHEWABLE TABLETS

Antihistamine

Relief of:

• Sneezing • Itchy, watery eyes

• Runny nose • Itchy throat

DYE

FREE

Actual Size

Bubble Gum Flavored

Child-Resistant Packaging

18 CHEWABLE TABLETS

Chew or crush tablets completely before swallowing.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Children’s Benadryl^® Chewables.

50844 REV1218C66944

√ CVS^® Quality

Money Back Guarantee

CVS 44-669

When Using This Product (When using this product)

avoid alcoholic beverages
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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)

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSE, UNSPECIFIED", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat", "Purpose": "Antihistamine", "Directions": "find right dose on chart below chew or crush tablets completely before swallowing; do not swallow tablets whole take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (yr) Dose (chewable tablets) 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 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, maltodextrin, mannitol, stearic acid, sucralose, triacetin", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "♥CVS Health ® Compare to the active ingredient in Children’s Benadryl ® Chewables* Chewable Tablets Children's Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE, 12.5 mg CHEWABLE TABLETS Antihistamine Relief of: • Sneezing • Itchy, watery eyes • Runny nose • Itchy throat DYE FREE Actual Size Bubble Gum Flavored Child-Resistant Packaging 18 CHEWABLE TABLETS Chew or crush tablets completely before swallowing. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Benadryl ® Chewables. 50844 REV1218C66944 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2021 CVS/pharmacy CVS.com ® 1-800-SHOP CVS √ CVS ® Quality Money Back Guarantee CVS 44-669", "When using this product": "avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children", "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": "glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "Active ingredient (in each chewable tablet)": "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