Help I Have a Stuffy Nose

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Help Remedies, Inc.
NDC Code: 49260-716

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.

Drugs Facts

Active Ingredient.............................Purpose
(in each tablet)

Phenylephrine HCl (5 mg)............................Nasal Decongestant


Uses
 Temporarily relieves nasal congestion due to:
• the common cold
• hay fever or other upper respiratory allergies
• helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure



Warnings

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 i your prescription drug contains an
MAOI, ask a doctor of 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.

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.

When using this product do not use more than directed

Keep out of reach of chidlren.

In case of accidental oversode, contact a doctor or Poison Control Center immediately.


If pregnant or breast feeding, ask a health professional before use.

Directions

• adults and children 12 years of age and over: 2 tablets (10 mg) every 4 hours. • do not exceed 12 tablets (60 mg) in 24 hours

• children under 12 years of age: Consult a doctor



Other Information
• store at room temperature 15-30 degrees C (59-86 degrees F) in a dry place • do not use if blister package is torn.• keep container. They contain important information.

Inactive Ingredients
microcrystalline cellulose, magnesium stearate, silicon dioxide, dicalcium phosphate, starch, stearic acid, croscarmellose sodium



Distributed by Help Remedies,

57 W. 28th St. Fl. 4
 
New York, NY 10001

www.helpineedhelp.com

HELP I HAVE A STUFFY NOSE 
phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-716
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (round tablet) Size7mm
FlavorImprint CodeFR4
Contains    
Packaging
#Item CodePackage Description
1NDC:49260-716-5050 TABLET (TABLET) in 1 BOTTLE
2NDC:49260-716-1616 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Labeler - Help Remedies, Inc. (050359682)
Registrant - Help Remedies, Inc. (050359682)

Revised: 07/2012
 
Help Remedies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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