0835k- Major

0835k- Major
SPL v4
SPL
SPL Set ID dca04d80-e781-40b1-e053-2995a90a7010
Route
ORAL
Published
Effective Date 2025-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: CPC;835 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-04-14 Until 2028-04-30

Description

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg


Medication Information

Description

Active ingredient (in each capsule) Diphenhydramine HCl 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 right away (1-800-222-1222).

Section 42229-5

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Benadryl®.

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

DO NOT USE IF RED CAPSULE BAND 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

 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

Major

BENOPHEN

NDC 0904-7237-24

Diphenhydramin HCl 25 mg

Antihistamine

For the temporary relief of the symptoms of:

• Upper Respiratory Allergies

• Hay Fever



Compare to the active ingredient in BENADRYL® Allergy*

24 CAPSULES

EACH CAPSULE INDIVIDUALLY

BANDED FOR YOUR PROTECTION

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 capsule)

Diphenhydramine HCl 25 mg

Other Information

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

Questions Or Comments?

1-800-616-2471


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 right away (1-800-222-1222).

Section 42229-5 (42229-5)

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Benadryl®.

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

DO NOT USE IF RED CAPSULE BAND 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)

 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)

Major

BENOPHEN

NDC 0904-7237-24

Diphenhydramin HCl 25 mg

Antihistamine

For the temporary relief of the symptoms of:

• Upper Respiratory Allergies

• Hay Fever



Compare to the active ingredient in BENADRYL® Allergy*

24 CAPSULES

EACH CAPSULE INDIVIDUALLY

BANDED FOR YOUR PROTECTION

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 this product

in children under 6 years of age

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Other Information (Other information)

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

Questions Or Comments? (Questions or comments?)

1-800-616-2471


Advanced Ingredient Data


Raw Label Data

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