Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ce711ae8-c2b8-423e-8241-1f322290ad9c
Route
ORAL
Published
Effective Date 2013-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Red No. 40 Hypromellose 2910 (50 Mpa.s) Hydroxypropyl Cellulose Cellulose, Microcrystalline Anhydrous Lactose Sodium Starch Glycolate Type A Potato Silicon Dioxide Stearic Acid Polyethylene Glycol 6000 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ZN75 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-01

Description

Diphenhydramine HCL 25mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 25mg

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
Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 25 mg (1 tablet)

children under 6 years of age

children under 4 years of age

ask a doctor

do not use

Package Label

Allergy Relief

Other Information
  • each tablet contains:calcium 0.1mg
  • store at 59° to 77°F in a dry place

  • protect from light

Inactive Ingredients

FD&C red no. 40, hypromellose 2910, hydroxypropyl cellulose, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, silicic acid anhydride, stearic acid, titanium dioxide

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Diphenhydramine HCL 25mg

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

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
Purpose

Antihistamine

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 25 mg (1 tablet)

children under 6 years of age

children under 4 years of age

ask a doctor

do not use

Package Label (Package label)

Allergy Relief

Other Information (Other information)
  • each tablet contains:calcium 0.1mg
  • store at 59° to 77°F in a dry place

  • protect from light

Inactive Ingredients (Inactive ingredients)

FD&C red no. 40, hypromellose 2910, hydroxypropyl cellulose, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, silicic acid anhydride, stearic acid, titanium dioxide

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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 accidental overdose get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCL 25mg

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

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

All Sections (JSON)