0835&0836(box Unit)-major

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Lactose, Unspecified Form Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: CPC;836 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2009-01-02 Until 2027-12-31

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg

.

Overbagged with 10 capsules per bag, NDC 55154-0661-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L32991870524

M-29	Rev. 10/16	Re-order No. 008237
M-29	Rev. 10/16	Re-order No. 008239
M-29	Rev. 03/23	Re-order No. 301575

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

50 MG

•
to make a child sleepy
•
with any other product containing diphenhydramine, including one applied topically

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

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.

Principal Display Panel

NDC 55154-0661-0

DIPHENHYDRAMINE HCl

CAPSULES 50 mg

10 CAPSULES

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

50 MG

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

Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Structured Label Content

.

Overbagged with 10 capsules per bag, NDC 55154-0661-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L32991870524

M-29	Rev. 10/16	Re-order No. 008237
M-29	Rev. 10/16	Re-order No. 008239
M-29	Rev. 03/23	Re-order No. 301575

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

50 MG

•
to make a child sleepy
•
with any other product containing diphenhydramine, including one applied topically

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

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.

Principal Display Panel

NDC 55154-0661-0

DIPHENHYDRAMINE HCl

CAPSULES 50 mg

10 CAPSULES

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

50 MG

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

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

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{".": "Overbagged with 10 capsules per bag, NDC 55154-0661-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L32991870524 M-29 Rev. 10/16 Re-order No. 008237 M-29 Rev. 10/16 Re-order No. 008239 M-29 Rev. 03/23 Re-order No. 301575", "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 50 MG • to make a child sleepy • with any other product containing diphenhydramine, including one applied topically", "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", "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.", "Principal Display Panel": "NDC 55154-0661-0 DIPHENHYDRAMINE HCl CAPSULES 50 mg 10 CAPSULES", "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 50 MG • glaucoma • a breathing problem such as emphysema or chronic bronchitis • 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