Benadryl Allergy Plus Congestion

Benadryl Allergy Plus Congestion
SPL v7
SPL
SPL Set ID 685b51d3-cc25-47b2-ac8a-368924f43137
Route
ORAL
Published
Effective Date 2020-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
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 Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PE;WL95 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-19

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

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

Section 53414-9

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

Section 55105-1
Active ingredients (in each tablet) Purposes
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant
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
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.
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

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
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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purposes
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 10 mg Nasal decongestant
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
Do Not Use (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.
Other Information (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 (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? (Questions or comments?)

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

Principal Display Panel (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

When Using This Product (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 (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)