Benadryl® ™ ALLERGY

BENADRYL  ALLERGY- diphenhydramine hydrochloride tablet, coated 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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 gelcap)

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

  • 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
  • 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

  • if needed, repeat dose every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years of age and over1 to 2 gelcaps
children 6 to under 12 years of age1 gelcap
children under 6 years of agedo not use this product in children under 6 years of age

Other information

  • each gelcap contains: calcium 35 mg
  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is open or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, crospovidone, D&C red #28, dibasic calcium phosphate dihydrate, edetate calcium disodium, FD&C red #40, gelatin, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, titanium dioxide, yellow iron oxide

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NDC 50580-580-49

Benadryl®

ALLERGY

Diphenhydramine HCl | Antihistamine

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

48

KAPGELS® 25 MG EACH
gelatin coated caplets

Principal Display Panel
BENADRYL   ALLERGY
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-580
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
ferrosoferric oxide 
butylparaben 
carboxymethylcellulose sodium 
crospovidone 
D&C red NO. 28 
calcium phosphate, dibasic, dihydrate 
edetate calcium disodium 
FD&C red NO. 40 
gelatin 
hypromelloses 
magnesium stearate 
methylparaben 
cellulose, microcrystalline 
polyethylene glycols 
polysorbate 80 
propylparaben 
ferric oxide red 
sodium lauryl sulfate 
sodium propionate 
titanium dioxide 
ferric oxide yellow 
Product Characteristics
ColorPINK, WHITE (with gray subcoat band) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code Ben;A
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-580-253 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:50580-580-496 in 1 CARTON
28 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/200910/31/2012
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 07/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc