0835 - Walgreen

0835 - Walgreen
SPL v4
SPL
SPL Set ID beb34c94-8370-e97d-e053-2995a90a59cc
Route
ORAL
Published
Effective Date 2021-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin Fd&c Red No. 40 D&c Red No. 28 Fd&c Blue No. 1 Lactose Monohydrate Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: CPC;835 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-07

Description

Active ingredient (in each capsule) Diphenhydramine HCI 25 mg


Medication Information

Description

Active ingredient (in each capsule) Diphenhydramine HCI 25 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

 temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2021 Walgreen Co.

PRODUCT OF JAPAN

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

†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks

 alcohol, sedatives and tranquilizers may increase drowsiness

 use caution when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

 a breathing problem such as emphysema or chronic bronchitis

 glaucoma

 trouble urinating due to an enlarged prostate gland

Section 50570-1

Do not use

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

Section 51727-6

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Section 51945-4

Walgreens

Compare to the active ingredient in Benadryl® Allergy††

NDC 0363-9835-01

Relieves allergy symptoms

Allergy Relief

Diphenhysramine HCl 25 mg / Antihistamine

Relief of runny nose, sneezing, itchy throat & itchy, watery eyes

100 Capsules

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Directions

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 1 to 2 capsules
children 6 to under 12 years of age 1 capsule
children under 6 years of age do not use

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCI 25 mg

Other Information

 store in a dry place at 15° – 30°C (59° – 86°F)

 protect from moisture

Questions Or Comments?

1-800-925-4733


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

 temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5 (42229-5)

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2021 Walgreen Co.

PRODUCT OF JAPAN

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

†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks

 alcohol, sedatives and tranquilizers may increase drowsiness

 use caution when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

 a breathing problem such as emphysema or chronic bronchitis

 glaucoma

 trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

Do not use

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Section 51945-4 (51945-4)

Walgreens

Compare to the active ingredient in Benadryl® Allergy††

NDC 0363-9835-01

Relieves allergy symptoms

Allergy Relief

Diphenhysramine HCl 25 mg / Antihistamine

Relief of runny nose, sneezing, itchy throat & itchy, watery eyes

100 Capsules

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Directions

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 1 to 2 capsules
children 6 to under 12 years of age 1 capsule
children under 6 years of age do not use

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCI 25 mg

Other Information (Other information)

 store in a dry place at 15° – 30°C (59° – 86°F)

 protect from moisture

Questions Or Comments? (Questions or comments?)

1-800-925-4733


Advanced Ingredient Data


Raw Label Data

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