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Childrens Allergy Relief by CVS Pharmacy

Medically reviewed on September 26, 2016

Dosage form: tablet, chewable
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg
Labeler: CVS Pharmacy
NDC Code: 59779-585

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.

CVS 44-585

Active ingredient (in each tablet)

Diphenhydramine HCl 12.5 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

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 (1-800-222-1222) right away.

Directions
  • dissolve in mouth or chew before swallowing
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 children under 2 years of age
 do not use
 children 2 to under 6 years
 of age

 do not use unless
 directed by a doctor

 children 6 to under 12 years
 of age
 1 to 2 tablets

 adults and children 12 years
 of age and over

 2 to 4 tablets

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, FD&C blue #1 aluminum lake, grape flavor art #554, magnesium stearate, mannitol, polyethylene and polypropylene polymers, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS Health™ 

Compare to the active ingredient in
Children's Benadryl® Allergy FastMelt® Tablets*

Rapid Melt

NDC 59779-585-44

Children's
Allergy 
Relief

DIPHENHYDRAMINE
HYDROCHLORIDE,12.5 mg
Antihistamine

Relief of:
•Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat

18 DISSOLVING TABLETS

Actual Size

Grape Flavored
Child-Resistant Packaging

TAMPER EVIDENT: DO NOT USE IF CARTON 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
Children's Benadryl® Allergy FastMelt® Tablets.
50844                                     REV0512A58544

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2015 CVS/pharmacy
CVS.com®    1-800-SHOP CVS
V-18615

CVS Quality
Money Back Guarantee

CVS 44-585


CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-585
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
DEXTRATES 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize12mm
FlavorGRAPEImprint Code44;585
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-585-443 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:59779-585-076 BLISTER PACK in 1 CARTON
26 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/20/2009
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(59779-585)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-585)

 
CVS Pharmacy

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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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