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Allergy Relief Dye-Free by CHAIN DRUG MARKETING ASSOCIATION INC

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-658

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.

Quality Choice 44-658

Active ingredient (in each liquid-filled capsule)

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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 (1-800-222-1222) 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 
1 to 2 capsules

children 6 to under 12
years of age 
1 capsule

children under 6 years
of age

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

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number

Inactive ingredients

edible white ink, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

QC®                                                       *Compare to the active Ingredient in BENADRYL® Dye-Free Allergy LIQUI-GELS®
QUALITY
CHOICE   
                                  

NDC 63868-658-08

Dye-Free
Allergy Relief

Complete Allergy Relief
Diphenhydramine HCl 25 mg / Antihistamine

Allergy Relief for:
Sneezing, Runny nose
Itchy, watery eyes, Itchy throat

24 Liquid-filled Capsules (25 mg Each)                            Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark BENADRYL® Dye-Free Allergy LIQUI-GELS®.
50844    ORG061465808

Product of China
Packaged and Quality Assured in the USA

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

SATISFACTION 100% QC GUARANTEED

Quality Choice 44-658

ALLERGY RELIEF  DYE-FREE
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-658
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorYELLOW (clear, natural) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code658
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-658-082 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2015
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(63868-658)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63868-658)

Revised: 02/2017
 
CHAIN DRUG MARKETING ASSOCIATION INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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