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


CVS Pharmacy, Inc. Allergy Capsules Drug Facts

ALLERGY - diphenhydramine hydrochloride capsule 
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 Capsules Drug Facts

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses {BLISTER CARTON CONFIGURATIONS ONLY}

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

Uses {100 COUNT BOTTLE-CARTON CONFIGURATION ONLY}

temporarily relieves symptoms due to hay fever, other upper respiratory allergies and the common cold

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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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 capsules
children 6 to under 12 years of age 1 capsule
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 {BLISTER CARTON CONFIGURATIONS ONLY}

  • store at room temperature (59°-86°F)
  • protect from moisture

Inactive ingredients

benzyl alcohol, butylparaben, D&C red no. 28, D&C yellow no. 10, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate

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 Capsules

Diphenhydramine Hydrochloride 25 mg

Antihistamine

For Allergy Relief

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

Allergy Capsules Carton

Allergy Capsules Carton


ALLERGY 
diphenhydramine hydrochloride capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-462
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Product Characteristics
Color PINK (clear) , WHITE (clear) , RED (band) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code L462
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-462-62 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-462-62)
2 NDC:59779-462-67 4 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 12 CAPSULE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-462-67)
3 NDC:59779-462-78 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
3 100 CAPSULE ( TABLET) in 1 BOTTLE This package is contained within the CARTON (59779-462-78)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/15/1987

Labeler - CVS Pharmacy (062312574)

Revised: 11/2009 CVS Pharmacy



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


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