BENADRYL-D ALLERGY AND SINUS- diphenhydramine hydrochloride and phenylephrine hydrochloride tablet 
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.

----------

Benadryl-D Allergy & Sinus

Drug Facts

Active ingredient (in each tablet)Purpose
Diphenhydramine HCl 25mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • sinus congestion and pressure
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
    • sinus congestion and pressure

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur a fever

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

Keep out of reach of children. In case of overdose, get medical help contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years and over
  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 14 hours
children under 12 yearsdo not use this product in children under 12 years of age

Other information

  • store between 20 - 25°C (68 - 77°F
  • 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, corn starch, FD&C blue #1 aluminum lake, magnesium stearate microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch, gylcolate, talc,titanium dioxide

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

Image not
available

Principal Display Panel
BENADRYL-D ALLERGY AND SINUS 
diphenhydramine hydrochloride and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-225
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
starch, corn 
FD&C blue No. 1 
aluminum oxide 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
polyvinyl alcohol 
powdered cellulose 
talc 
titanium dioxide 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize13mm
FlavorImprint Code B;WL;95
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-225-242 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/200802/29/2012
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 12/2013
Document Id: 40b2e9c1-ef98-461a-a60c-a8635a06d147
Set id: 9f563fba-76e7-4755-b2a5-a694a5df205a
Version: 1
Effective Time: 20131205
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc