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Allergy Relief by Chain Drug Marketing Association

Medically reviewed on October 30, 2017

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Chain Drug Marketing Association
NDC Code: 63868-492

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.

1090 - QCH - 2014-1028

Drug Facts

Active ingredient (in each tablet)

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 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
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

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 exceed 6 doses in 24 hours
12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age12.5 mg to 25 mg (1 tablet)
children under 6 years of ageask a doctor

Other information
  • each tablet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 63868-492-24

QUALITY CHOICE

†Compare to Active Ingredient in BENADRYL® Allergy

Allergy Relief

Antihistamine

Diphenhydramine HCl, 25 mg

For Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Tablets

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-492
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code25;052
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-492-242 BLISTER PACK in 1 CARTON
112 TABLET, COATED in 1 BLISTER PACK
2NDC:63868-492-101 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/13/2014
Labeler - Chain Drug Marketing Association (011920774)

 
Chain Drug Marketing Association

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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