FDA Label for Allergy Plus Congestion Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Allergy Plus Congestion Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Woonsocket Prescription Center, Incorporated. 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.
Active Ingredients (In Each Tablet)
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- nasal congestion
- itching of the nose or throat
- itchy, watery eyes
- temporarily relieves these symptoms due to the common cold:
- nasal congestion
- runny nose
- sneezing
- temporarily relieves sinus congestion and pressure
Do Not Use
- 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.
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- difficulty in urination due to enlargement of the prostate gland
- diabetes
- thyroid disease
- heart disease
- glaucoma
- high blood pressure
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- symptoms do not improve within 7 days or are accompanied by fever
- nervousness, dizziness, or sleeplessness occur
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.
Directions
- do not take more than directed
- 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: do not use
Other Information
- each tablet contains: calcium 25 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Compare to the active ingredients in
Benadryl® Allergy Plus Congestion*
Tablets
Allergy Plus
Congestion Relief
DIPHENHYDRAMINE HCl - Antihistamine
PHENYLEPHRINE HCl - Nasal decongestant
Relief of:
- Sneezing
- Runny nose
- Sinus congestion
- Sinus pressure
- Itchy throat
- Itchy, watery eyes
Actual Size
24 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED #197895
OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Benadryl®
Allergy Plus Congestion.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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