VALURX DYE FREE ALLERGY RELIEF- diphenhydramine hci 25 mg capsule, liquid filled

ValuRx Dye Free Allergy Relief by

Drug Labeling and Warnings

ValuRx Dye Free Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Shield Pharmaceuticals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each soft gel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

WARNINGS

Do not use

• to make a child sleepy 
• with any other product containing diphenhydramine, even one used on skin

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

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

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

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).

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

Other information

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

Inactive ingradient

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

Questions or comments?

1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779

Principal display

Label

Carton

INGREDIENTS AND APPEARANCE

VALURX DYE FREE ALLERGY RELIEF 
diphenhydramine hci 25 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83059-0080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	SD12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83059-0080-1	1 in 1 BOX	02/17/2025
1		12 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/17/2025

Labeler - Shield Pharmaceuticals Corp (118724924)