DYE-FREE ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled
PuraVation Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DYE-FREE ALLERGY RELIEF capsule, liquid filled

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

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.

Directions

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

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

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 special and white edible ink

PRINCIPAL DISPLAY PANEL - 24 SOFTGEL CARTON

ALLERGY RELIEF

NDC # 76270-108-04

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

Diphenhydramine HCl

Antihistamine

Temporary Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

Dye-Free

24 SOFTGELS

25 mg each

PRINCIPAL DISPLAY PANEL - Shipping Label

DYE-FREE ALLERGY RELIEF
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76270-108
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76270-108-04	2 in 1 CARTON	09/12/2013	12/30/2016
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	09/12/2013	12/30/2016

Labeler - PuraVation Pharmaceuticals Inc (968385034)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(76270-108) , ANALYSIS(76270-108)

Revised: 12/2016

Document Id: 9df8bcf5-299e-4ffc-8343-1fcabd217d5f

Set id: 83ded8f1-1b3b-4a36-aa67-2b59fce7c929

Version: 2

Effective Time: 20161230

PuraVation Pharmaceuticals Inc