ALLERGY- diphenhydramine hydrochloride capsule 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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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Active ingredient (in each banded 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

  • 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 of 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 take more than 6 doses in 24 hours
    adults and children 12 years of age and over1 to 2 capsules 
    children 6 to under 12 years of age1 capsule 
    children under 6 years of agedo not use this product in children under 6 years of age 

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS®

pharmacy

Compare to the active

ingredient in Benadryl®*

SEE NEW WARNING

AND DOSING DIRECTIONS

ALLERGY

CAPSULES

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

ANTIHISTAMINE

FOR ALLERGY RELIEF

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat

TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

50844         REV0810A19008

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2010 CVS/pharmacy

Product Packaging

Product Packaging

ALLERGY 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-019
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
D&C RED NO. 28 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
PROPYLPARABEN 
POLYSORBATE 80 
Product Characteristics
ColorPINK (and white with red band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 44;107
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-019-071 in 1 CARTON
136 in 1 BLISTER PACK
2NDC:59779-019-081 in 1 CARTON
224 in 1 BLISTER PACK
3NDC:59779-019-221 in 1 CARTON
348 in 1 BLISTER PACK
4NDC:59779-019-061 in 1 CARTON
4200 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33603/15/1990
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 08/2011
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED