ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet 
P and L Development of New York Corporation

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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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

  • 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 right away. (1-800-222-1222)

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 over take 1 to 2 tablets 
children 6 to under 12 years of age take 1 tablet
children under 6 years of age do not use this product in children under 6

Other information

  • each tablet contains: calcium 25 mg/tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide

* contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Benadryl® Allergy Ultratab®

Allergy Tablets

Diphenhydramine HCl, 25 mg

Antihistamine

For Allergy Relief

Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat

TABLETS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy ULTRATAB®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY  11590

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Diphenhydramine HCl 25 mg

PL Developments Allergy Tablet

ALLERGY  ANTIHISTAMINE
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59726-691
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
EGG PHOSPHOLIPIDS 
WATER 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code T;061;V;25;S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-691-122 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:59726-691-011 in 1 BOX
2100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33608/27/2013
Labeler - P and L Development of New York Corporation (800014821)

Revised: 9/2013
Document Id: 94b7ea94-f521-4c92-9f07-a04f5fba91d2
Set id: 2ab08150-6b41-4901-a4fa-cd571b1cd078
Version: 1
Effective Time: 20130910
 
P and L Development of New York Corporation