0835&0836(box Unit)-major

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 Gelatin, Unspecified Anhydrous Lactose 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 2009-01-02

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg

Use

25 MG

•
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- o
  runny nose
- o
  sneezing
- o
  itchy, watery eyes
- o
  itchy throat and nose
•
Temporarily relieves these symptoms due to the common cold:
- o
  runny nose
- o
  sneezing

50 MG

•
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- o
  sneezing
- o
  runny nose
- o
  itchy, watery eyes
- o
  itchy throat and nose

Warnings

Do not use

25 MG

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

Directions

•
Take every 4-6 hours
•
Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over	1 to 2 capsules
children 6 years 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

50 MG

adults and children 12 years of age and over	1 capsule
children 6 years to under 12 years of age	Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Questions?

Questions or comments? (800) 616-2471

Distributed By

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

-

Livonia, MI 48152

Repackaged by Preferred Pharmaceuticals, Inc.

NDC 68788-7589

Other Information

•
Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
•
Protect from moisture
•
Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

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

Ask A Doctor Or Pharmacist

before use if you are taking sedatives or tranquilizers

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

25 MG

•
a breathing problem such as emphysema or chronic bronchitis
•
glaucoma
•
trouble urinating due to an enlarged prostate gland
•
difficulty in urination due to enlargement of the prostate gland

Package Label.principal Display Panel

Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Structured Label Content

Use

25 MG

•
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- o
  runny nose
- o
  sneezing
- o
  itchy, watery eyes
- o
  itchy throat and nose
•
Temporarily relieves these symptoms due to the common cold:
- o
  runny nose
- o
  sneezing

50 MG

•
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- o
  sneezing
- o
  runny nose
- o
  itchy, watery eyes
- o
  itchy throat and nose

Purpose

Antihistamine

Warnings (WARNINGS)

Do not use

25 MG

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

Directions

•
Take every 4-6 hours
•
Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over	1 to 2 capsules
children 6 years 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

50 MG

adults and children 12 years of age and over	1 capsule
children 6 years to under 12 years of age	Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Questions?

Questions or comments? (800) 616-2471

Distributed By (Distributed by)

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

-

Livonia, MI 48152

Repackaged by Preferred Pharmaceuticals, Inc.

NDC 68788-7589

Other Information

•
Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
•
Protect from moisture
•
Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

When Using This Product (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

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

before use if you are taking sedatives or tranquilizers

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)

25 MG

•
a breathing problem such as emphysema or chronic bronchitis
•
glaucoma
•
trouble urinating due to an enlarged prostate gland
•
difficulty in urination due to enlargement of the prostate gland

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Active Ingredient (in Each Banded Capsule) (Active Ingredient (in each banded capsule))

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Advanced Ingredient Data

[{"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "25 MG • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o itchy throat and nose • Temporarily relieves these symptoms due to the common cold: o runny nose o sneezing 50 MG • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold o sneezing o runny nose o itchy, watery eyes o itchy throat and nose", "Purpose": "Antihistamine", "WARNINGS": "Do not use 25 MG • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin", "Directions": "• Take every 4-6 hours • Do not take more than 6 doses in 24 hours 25 MG adults and children 12 years of age and over 1 to 2 capsules children 6 years 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 50 MG adults and children 12 years of age and over 1 capsule children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.", "Questions?": "Questions or comments? (800) 616-2471", "Distributed by": "MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, - Livonia, MI 48152 Repackaged by Preferred Pharmaceuticals, Inc. NDC 68788-7589", "Other Information": "• Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature] • Protect from moisture • Contains lactose", "Inactive Ingredients": "D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.", "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", "Ask a doctor or pharmacist": "before use if you are taking sedatives or tranquilizers", "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": "25 MG • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland • difficulty in urination due to enlargement of the prostate gland", "Active Ingredient (in each banded capsule)": "Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information