Allergy Relief

Allergy Relief
SPL v2
SPL
SPL Set ID 8a004e36-59dd-4955-b344-852ac52cdeed
Route
ORAL
Published
Effective Date 2019-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin Glycerin Polyethylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: PC4 Shape: capsule Color: yellow Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-05-29

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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 42229-5

Drug Facts

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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

adults and children 12 years and over

     1 to 2 softgels

children 6 to under 12 years

     1 softgel

children under 6 years

     do not use this product in children under 6 years of age

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • store at room temperature 15°-30°C (59°-86°F) 
  • protect from heat, humidity, and light
Inactive Ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions Or Comments?

Call toll free: 1-888-423-0136

Principal Display Panel

Allergy Relief

Diphenhydramine HCl 25 mg 100 softgels

NDC 36800-436-24

*Compare to the active ingredient in Benadryl® Dye-Free Allergy Liqui-Gels®

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
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)

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 42229-5 (42229-5)

Drug Facts

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

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

adults and children 12 years and over

     1 to 2 softgels

children 6 to under 12 years

     1 softgel

children under 6 years

     do not use this product in children under 6 years of age

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 room temperature 15°-30°C (59°-86°F) 
  • protect from heat, humidity, and light
Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-888-423-0136

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Allergy Relief

Diphenhydramine HCl 25 mg 100 softgels

NDC 36800-436-24

*Compare to the active ingredient in Benadryl® Dye-Free Allergy Liqui-Gels®

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
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)

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)