Valurx Dye-free Allergy Relief

Valurx Dye-free Allergy Relief
SPL v3
SPL
SPL Set ID 265cf6cf-fe9e-4452-9071-e28989847c2c
Route
ORAL
Published
Effective Date 2025-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Povidone Water Sorbitol Solution Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: SD12 Shape: capsule Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-17

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 
  • itchy, watery eyes
  • sneezing 
  • itching of the nose or throat 
  • temporarily relieves these
  • symptoms due to the common cold: 
  • runny nose 
  • sneezing
Section 42229-5

Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779

Section 50565-1

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).

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 53414-9

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

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times 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
Do Not Use
  • to make a child sleepy 
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Other Information
  • store between 20-25° C (68-77° F)
  • Avoid high humidity and excessive heat
  • protect from moisture and light
Principal Display

Label

Carton

Inactive Ingradient

gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-373-6981

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

Diphenhydramine HCl 25 mg


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose 
  • itchy, watery eyes
  • sneezing 
  • itching of the nose or throat 
  • temporarily relieves these
  • symptoms due to the common cold: 
  • runny nose 
  • sneezing
Section 42229-5 (42229-5)

Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779

Section 50565-1 (50565-1)

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).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking 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, or as directed by a doctor
  • do not take more than 6 times 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
Do Not Use (Do not use)
  • to make a child sleepy 
  • with any other product containing diphenhydramine, even one used on skin
Drug Facts

Other Information (Other information)
  • store between 20-25° C (68-77° F)
  • Avoid high humidity and excessive heat
  • protect from moisture and light
Principal Display (Principal display)

Label

Carton

Inactive Ingradient (Inactive ingradient)

gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-800-373-6981

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 Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis 
  • trouble urinating due to an enlarged
  • prostate gland 
  • glaucoma
Active Ingredient (in Each Soft Gel) (Active ingredient (in each soft gel))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)