Topcare 44-585

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Mannitol Stearic Acid Sucralose Sucrose

Identifiers & Packaging

Pill Appearance

Imprint: 44;585 Shape: round Color: purple Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-03-20

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

Warnings

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

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

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

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments?

1-888-423-0139

Principal Display Panel

+TopCare_®

health

NDC 36800-585-44

COMPARE TO CHILDREN'S BENADRYL® CHEWABLES ACTIVE INGREDIENT*

children's

Allergy Relief

DIPHENHYDRAMINE HCl 12.5 mg

CHEWABLE TABLETS - ANTIHISTAMINE

4-6

HOURS/

DOSE

RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Nose or Throat

18 CHEWABLE

TABLETS

Chew or crush tablets completely before swallowing.

For Ages 6 to 11 Years

GRAPE

FLAVOR

actual size

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 REV1218B58544

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0521

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

QUALITY

GUARANTEED

Topcare 44-585

When Using This Product

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

Warnings

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)

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

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)

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel

+TopCare_®

health

NDC 36800-585-44

COMPARE TO CHILDREN'S BENADRYL® CHEWABLES ACTIVE INGREDIENT*

children's

Allergy Relief

DIPHENHYDRAMINE HCl 12.5 mg

CHEWABLE TABLETS - ANTIHISTAMINE

4-6

HOURS/

DOSE

RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Nose or Throat

18 CHEWABLE

TABLETS

Chew or crush tablets completely before swallowing.

For Ages 6 to 11 Years

GRAPE

FLAVOR

actual size

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 REV1218B58544

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0521

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

QUALITY

GUARANTEED

Topcare 44-585

When Using This Product (When using this product)

alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages
marked drowsiness may occur
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": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30 ALUMINUM LAKE", "unii": "GE75M6YV5W", "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": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "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": "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": "SUCROSE", "unii": "C151H8M554", "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": "with any other product containing diphenhydramine, even one used on skin to make a child sleepy", "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": "D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose", "Questions or comments?": "1-888-423-0139", "Principal Display Panel": "+TopCare ® health NDC 36800-585-44 COMPARE TO CHILDREN'S BENADRYL® CHEWABLES ACTIVE INGREDIENT* children's Allergy Relief DIPHENHYDRAMINE HCl 12.5 mg CHEWABLE TABLETS - ANTIHISTAMINE 4-6 HOURS/ DOSE RELIEF OF: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Nose or Throat 18 CHEWABLE TABLETS Chew or crush tablets completely before swallowing. For Ages 6 to 11 Years GRAPE FLAVOR actual size 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 REV1218B58544 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com QUALITY GUARANTEED Topcare 44-585", "When using this product": "alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages marked drowsiness may occur 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