FDA Label for Sinus And Allergy Maximum Strength
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
Sinus And Allergy Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium. 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)
Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- sinus congestion and pressure
- nasal congestion
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.
Ask A Doctor Before Use If You Have
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
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: do not use this product in children under 12 years of age
Other Information
- 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, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Premier
Value®
NDC 68016-687-24
*COMPARE TO THE ACITVE INGREDIENTS IN
SUDAFED PE® SINUS + ALLERGY
Maximum Strength
Sinus & Allergy
Chlorpheniramine maleate 4 mg - ANTIHISTAMINE
Phenylephrine HCl 10 mg - NASAL DECONGESTANT
• Sneezing
• Itchy eyes
• Runny nose
• Sinus pressure + congestion
24 Tablets
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus + Allergy.
50844 ORG061246208
DISTRIBUTED BY: CHAIN CONSORTIUM, LLC
UPARC, BLDG. A3, SUITE 338
1020 WILLIAM PITT WAY
PITTSBURGH, PA 15238
www.chaindrugconsortium.com
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
* Please review the disclaimer below.