0835k- Major

0835k- Major
SPL v3
SPL
SPL Set ID 5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2
Route
ORAL
Published
Effective Date 2024-03-12
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, Unspecified 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 Active Since 2022-04-14

Description

Active ingredient (in each capsule) Diphenhydramine HCl 25 mg

How Supplied

Product: 50090-7014 NDC: 50090-7014-0 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE


Medication Information

How Supplied

Product: 50090-7014

NDC: 50090-7014-0 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

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

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

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

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

To preserve quality and freshness, keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE

TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

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 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

Diphenhydramine Hydrochloride

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

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

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

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

To preserve quality and freshness, keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE

TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

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 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

How Supplied (HOW SUPPLIED)

Product: 50090-7014

NDC: 50090-7014-0 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

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

Diphenhydramine Hydrochloride

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)