FDA Label for Benadryl Allergy Plus Congestion
View Indications, Usage & Precautions
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Benadryl Allergy Plus Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
| 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
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 |
|
| 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
* Please review the disclaimer below.