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Benadryl Allergy Plus Congestion

Package insert / prescribing information
Generic name: diphenhydramine hydrochloride and phenylephrine hydrochloride
Dosage form: tablet, film coated
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Jul 22, 2022.

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.

Drug Facts

Active ingredients (in each tablet) Purposes
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant

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
    • nasal congestion
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
  • temporarily relieves sinus congestion and pressure

Warnings

Do not use

  • to make a child sleepy
  • 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
  • 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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with 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 or 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 24 hours
children under 12 years ask a doctor

Other information

  • store between 20-25°C (68-77°F).
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-415-01

Benadryl®

ALLERGY PLUS
CONGESTION

Diphenhydramine HCl 25mg | Antihistamine
Phenylephrine HCl 10mg | Nasal Decongestant

✓ Sneezing
✓ Runny Nose
✓ Sinus Congestion
✓ Itchy, Watery Eyes
✓ Itchy Throat
✓ Sinus Pressure

ULTRATABS®*
*small tablet size

actual size

24 TABLETS

Benadryl Allergy Plus Congestion
diphenhydramine hydrochloride and phenylephrine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-415
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 25 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
FD&C blue no. 1 aluminum lake
magnesium stearate
microcrystalline cellulose
polyethylene glycol, unspecified
polyvinyl alcohol, unspecified
powdered cellulose
sodium starch glycolate type A potato
talc
titanium dioxide
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code PE;WL95
Contains
Packaging
# Item Code Package Description
1 NDC:50580-415-01 2 BLISTER PACK in 1 CARTON
1 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/19/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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