0835k-cvs

0835k-cvs
SPL v2
SPL
SPL Set ID f4468840-e17c-6888-e053-2995a90a04a0
Route
ORAL
Published
Effective Date 2023-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: CPC;835 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-16

Description

Active ingredient (in each banded capsule) Diphenhydramine HCI 25 mg


Medication Information

Description

Active ingredient (in each banded 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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-34601

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

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

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

 be careful 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

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Section 51945-4

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE

25 mg - Antihistamine

Relief of: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

100 CAPSULES

Section 53413-1

Questions or comments? 1-800-231-4670

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 this product in

children under 6 years of age

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg

Other Information

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

 protect from moisture


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)

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS V-34601

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

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

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

 be careful 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)

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Section 51945-4 (51945-4)

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE

25 mg - Antihistamine

Relief of: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

100 CAPSULES

Section 53413-1 (53413-1)

Questions or comments? 1-800-231-4670

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Directions (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 this product in

children under 6 years of age

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg

Other Information (Other information)

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

 protect from moisture


Advanced Ingredient Data


Raw Label Data

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