NASAL AND SINUS DECONGESTANT- nasal and sinus decongestant tablet 
Redicare LLC

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.

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Decongestant

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

Phenylephrine HCI 5 mg.......................................................................................................Decongestant

Uses:

Temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus opening and passages ■ restores free breathing

Warnings:

Do not use:

■ more than recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains a MAOI, consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if

■ symptoms do not improve ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have:

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland

If pregnant or breast-feeding a baby,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: consult a doctor

Other Information:

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

Inactive Ingredients:

corsscarmellose sodium, D&C Red #28, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

Decongestant

NASAL AND SINUS DECONGESTANT 
nasal and sinus decongestant tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize6mm
FlavorImprint Code FR4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71105-333-68100 in 1 CARTON; Type 0: Not a Combination Product10/01/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2017
Labeler - Redicare LLC (800149346)

Revised: 7/2021
Document Id: c62a10de-a0bc-308c-e053-2995a90a8f59
Set id: 47e0830f-31e4-5ff0-e054-00144ff88e88
Version: 3
Effective Time: 20210702
 
Redicare LLC