Benadryl Allergy Plus Congestion Tablet, Film Coated
FDA Label NDC 50580-415

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Benadryl Allergy Plus Congestion (NDC 50580-415). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each tablet)Purposes
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 10 mgNasal 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

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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 yearsask 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

Principal Display Panel (Benadryl 01)

Principal Display Panel (Benadryl 01)

* Please review the disclaimer below.