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Name:Allergy
Manufacturer:Cvs Pharmacy
Category:Over-the-counter (OTC) Marketed Drugs


CVS Pharmacy, Inc. Allergy Tablets Drug Facts

ALLERGY - diphenhydramine hydrochloride tablet 
CVS Pharmacy

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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CVS Pharmacy, Inc. Allergy Tablets Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

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
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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, not more than 6 doses in 24 hours
adults and children 12 years of age and over 1 or 2 tablets
children 6 to under 12 years of age 1 tablet
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use

Other information

  • each tablet contains: calcium 20 mg
  • store at 20°-25°C

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Benadryl® Allergy

See New Warning and Dosing Directions

Allergy Tablets

Diphenhydramine Hydrochloride 25 mg

Antihistamine

For Allergy Relief

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

Easy to Swallow

Small Tablet Size

Allergy Tablets Carton

Allergy Tablets Carton

Easy to Swallow


ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-479
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
CROSPOVIDONE  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYSORBATE 80  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color PINK (dark) Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code L479
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-479-62 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 12 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-479-62)
2 NDC:59779-479-67 4 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 12 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-479-67)
3 NDC:59779-479-68 3 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
3 12 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-479-68)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/14/1991

Labeler - CVS Pharmacy (062312574)

Revised: 07/2009 CVS Pharmacy



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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