ALLERGY RELIEF DYE FREE- diphenhydramine hcl capsule, liquid filled

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing,  runny nose

Warnings

Do not use

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

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

Ask a doctor or pharmacist before use if you are

taking 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
• do not take more than 6 doses in 24 hours
• swallow whole; do not crush, chew or dissolve
• adults and children 12 years of age and over - take 1 to 2 softgels
• children 6 to under 12 years of age              - take 1 softgel
• children under 6 years of age                      - do not use

Other information

• store between 20-25ºC (68 to 77°F). Avoid high humidityandexcessive heat.
• Protect from light, heat, humidity

Inactive ingredients

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

Questions or comments?

Call 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Dye-Free LIQUI-GELS® active ingredient*

Allergy Relief

Diphenhydramine HCl 25 mg/Antihistamine

Dye-Free

temporarily Relieves:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
Softgels

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®, or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF   DYE FREE
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-933
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)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	611
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-933-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/06/2020

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PVT LTD		677385498	manufacture(36800-933)