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Benadryl Allergy

Medically reviewed on April 13, 2018

Dosage form: tablet, coated
Ingredients: Diphenhydramine Hydrochloride 25mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-811

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.

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 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

BENADRYL  ALLERGY
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-811(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
butylparaben 
Product Characteristics
ColorPINK, WHITE (with gray subcoat band) Scoreno score
ShapeOVALSize15mm
FlavorImprint CodeBen;A
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-811-243 BLISTER PACK (BLISTER PACK) in 1 CARTON
18 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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