ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled 
PuraCap Pharmaceutical LLC

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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Nighttime SLEEP AID

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:
   o runny nose
   o sneezing
   o itchy, watery eyes
   o itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
   o runny nose
   o 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 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 or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Keep out of reach of children.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and overtake 1 to 2 softgels 
children 6 to under 12 years of agetake 1 softgel
children under 6 years of age do not take this product in children under 6 years of age 

Other information

Inactive ingredients

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

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL - Carton Label

PuraVation Allergy Relief 

Diphenhydramine HCl - 25 mg EACH

12 LIQUID-FILLED SOFTGELS

NDC 51013-108-02

Carton Label

ALLERGY RELIEF 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Coloryellow (clear) Scoreno score
Shapecapsule (oblong) Size15mm
FlavorImprint Code PC4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-108-021 in 1 CARTON05/12/2014
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/12/2014
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(51013-108) , analysis(51013-108)

Revised: 6/2016
Document Id: 46932ce6-af48-4b2e-8d2a-34e5d28edcca
Set id: 4b901ebb-ec05-4a5f-8939-071a562e780f
Version: 1
Effective Time: 20160627
 
PuraCap Pharmaceutical LLC