Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 751f13d4-c4d6-47a5-b40d-1563de08c048
Route
ORAL
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Ferrosoferric Oxide D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose Monohydrate Magnesium Stearate Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: PH014 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

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 51945-4

PHARBEST

NDC 73057-348-08

Manufactured in the USA

*COMPARE TO the active ingredient in

BENADRYL ®ALLERGY ULTRATAB ®

ALLERGY RELIEF

Antihistamine - Diphenhydramine HCl 25 mg

• Itchy, Watery Eyes • Runny Nose

• Itchy Throat • Sneezing

100 CAPSULES

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not exceed 6 doses in 24 hours
 adults and children 12 years and over  1 to 2 capsules
 children 6 to under 12 years  1 capsule
 children under 6 years ask a doctor

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • store at 20-25 oC (68-77 oF)
Inactive Ingredients

black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions Or Comments?

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

When Using This Product
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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 (1-800-222-1222).

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


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 51945-4 (51945-4)

PHARBEST

NDC 73057-348-08

Manufactured in the USA

*COMPARE TO the active ingredient in

BENADRYL ®ALLERGY ULTRATAB ®

ALLERGY RELIEF

Antihistamine - Diphenhydramine HCl 25 mg

• Itchy, Watery Eyes • Runny Nose

• Itchy Throat • Sneezing

100 CAPSULES

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not exceed 6 doses in 24 hours
 adults and children 12 years and over  1 to 2 capsules
 children 6 to under 12 years  1 capsule
 children under 6 years ask a doctor

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (Other information)
  • store at 20-25 oC (68-77 oF)
Inactive Ingredients (Inactive ingredients)

black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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 (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Active Ingredient (in Each Banded Capsule) (Active ingredient (in each banded capsule))

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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