DYE-FREE ALLERGY- diphenhydramine hydrochloride capsule, liquid filled

DYE-FREE ALLERGY by

Drug Labeling and Warnings

DYE-FREE ALLERGY by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

• 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
• glaucoma
• trouble urinating due to an enlarged prostate gland

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

• 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

Other information

• store at room temperature 15°-30°C (59°-86°F) in a dry place
• protect from heat, humidity, and light

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

DYE-FREE ALLERGY 24 SOFTGELS

Diphenhydramine HCl 25mg

NDC: 51013-144-04

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

INGREDIENTS AND APPEARANCE

DYE-FREE ALLERGY 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-144
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	yellow (clear)	Score	no score
Shape	capsule (oblong)	Size	15mm
Flavor		Imprint Code	PC4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-144-04	2 in 1 CARTON	06/27/2016
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/27/2016

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(51013-144) , analysis(51013-144)