HELP I HAVE A STUFFY NOSE- phenylephrine tablet

Help I Have a Stuffy Nose by

Drug Labeling and Warnings

Help I Have a Stuffy Nose by is a Otc medication manufactured, distributed, or labeled by Help Remedies, Inc. , Help Remedies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

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

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.

DO NOT USE

When using this product do not use more than directed

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of chidlren.

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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 INGREDIENT

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

QUESTIONS

Distributed by Help Remedies,

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

www.helpineedhelp.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELP I HAVE A STUFFY NOSE 
phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49260-716
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (round tablet)	Size	7mm
Flavor		Imprint Code	FR4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49260-716-50	50 in 1 BOTTLE
2	NDC: 49260-716-16	16 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2012

Labeler - Help Remedies, Inc. (050359682)

Registrant - Help Remedies, Inc. (050359682)