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Name:Benadrylallergy
Manufacturer:Rebel Distributors Corp
Category:Over-the-counter (OTC) Marketed Drugs


Benadryl®™ALLERGY

BENADRYL ALLERGY - diphenhydramine hydrochloride tablet, coated 
Rebel Distributors Corp

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®
ALLERGY

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 over 1 to 2 gelcaps
children 6 to under 12 years of age 1 gelcap
children under 6 years of age do 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

Benadryl 25mg


BENADRYL  ALLERGY
diphenhydramine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-811(NDC:50580-580)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
butylparaben  
Product Characteristics
Color PINK, WHITE (with gray subcoat band) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Ben;A
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-811-24 3 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 8 TABLET, COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (21695-811-24)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/01/2009

Labeler - Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 04/2011 Rebel Distributors Corp



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


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