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  5. Label Information: Phenylephrine Hydrochloride

FDA Label for Phenylephrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL - 36 TABLET BLISTER PACK CARTON

Phenylephrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Aaa Pharmaceutical, 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

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048


Active Ingredient (In Each Tablet)



Phenylephrine HCl 10 mg


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis
  • temporarily relieves sinus congestion and pressure

Otc - Do Not Use



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



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When Using This Product



  • do not use more than directed

Stop Use And Ask A Doctor If



  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by 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.


Directions



  • adults and children 12 years of age and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
  • children under 12 years of age: ask a doctor

Other Information



  • store at 15°-25°C (59°-77°F) in a dry place
  • retain carton for complete product information

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide


Principal Display Panel - 36 Tablet Blister Pack Carton



RESTORE u

NDC 57344-131-03

†COMPARE TO THE ACTIVE
INGREDIENT IN SUDAFED PE®
NASAL DECONGESTANT

MAXIMUM
STRENGTH

NON-DROWSY

Nasal Decongestant PE

Phenylephrine HCl

Relieves: • Nasal & Sinus Congestion • Sinus Pressure

36 TABLETS - 10 mg each


* Please review the disclaimer below.