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Name:Benadryl
Manufacturer:Mcneil Consumer Healthcare Div Mcneil-ppc, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Benadryl®

BENADRYL - diphenhydramine hydrochloride tablet, film 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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Benadryl®

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

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 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 times in 24 hours
adults and children 12 years and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use this product in children under 6 years of age

Other information

  • each tablet contains: calcium 15 mg
  • store between 20 - 25°C (68 - 77°F). Avoid high humidity. Protect from light.
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, crospovidone, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NEW
LOOK!
SAME RELIEF

NDC 50580-226-24

Benadryl®

ALLERGY

Diphenhydramine HCl | Antihistamine

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

24
ULTRATAB™* TABLETS
25 MG EACH
*small tablet size

Principal Display Panel - 24 Tablets Carton

BENADRYL  
diphenhydramine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-226
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine 25 mg
Product Characteristics
Color PINK Score no score
Shape OVAL Size 11mm
Flavor Imprint Code B;WL;25
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-226-02 60 POUCH ( POUCH) in 1 CARTON contains a POUCH
1 2 TABLET, FILM COATED ( TABLET) in 1 POUCH This package is contained within the CARTON (50580-226-02)
2 NDC:50580-226-10 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (50580-226-10)
3 NDC:50580-226-11 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
3 100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (50580-226-11)
4 NDC:50580-226-14 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
4 148 TABLET, FILM COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (50580-226-14)
5 NDC:50580-226-24 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
5 12 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (50580-226-24)
6 NDC:50580-226-48 4 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
6 12 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (50580-226-48)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part342 09/01/2008

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 09/2009 McNeil Consumer Healthcare Div McNeil-PPC, Inc



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


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