Benadryl Allergy Plus Congestion: Package Insert / Prescribing Information - Drugs.com

Skip to main content
Print
Save

# 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)

## Related/similar drugs

prednisone, amoxicillin, azithromycin, ciprofloxacin, fluticasone nasal, levofloxacin, loratadine

## 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

## More about Benadryl Allergy Plus Congestion (diphenhydramine / phenylephrine)

- Check interactions
- Pricing & coupons
- Side effects
- Dosage information
- During pregnancy
- Drug class: upper respiratory combinations

### Related treatment guides

- Allergic Rhinitis
- Cold Symptoms
- Sinusitis

Medical Disclaimer