DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet, coated 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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

Warnings

Do not use

Do not use 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
  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

  • excitability may occur especially in children
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when operating machinery or driving a motor vehicle

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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    take 1 or 2 tablets
    children 6 to under 12 years of age    take 1 tablet
    children under 6 years of age    consult a doctor
    children under 4 years of age   do not use

Other information

  • each tablet contains: calcium 25 mg/tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture
  • *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs.

Inactive ingredients

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

Package/Label Principal Display Panel

Allergy Tablets Packaging Label

NDC 63548-6373-*1

*Compare to the active ingredient in Benadryl® Allergy Ultratabs®

Antihistamine

Allergy Tablets

Diphenhydramine Hydrochloride 25 mg

For Allergy Relief

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

24 Tablets


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

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-3482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize4mm
FlavorImprint Code V25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-3482-124 in 1 BLISTER PACK; Type 0: Not a Combination Product01/02/201002/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/02/201002/28/2017
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017
Document Id: 01ac6d37-cdef-4a86-a95b-43e528ed4a9e
Set id: f0ef7742-a09e-4d1b-9658-e9c0ba8ee003
Version: 2
Effective Time: 20170331
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions