NASAL DECONGESTANT PE  10MG- phenylphrine hcl tablet 
YYBA CORP

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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YYBA - WELMATE - Nasal Decongestant PE Tablets, 10 MG

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
  • temporarily relieves sinus congestion and pressure

Warnings

Do not use if you are taking a prescription monoamine oxidase inhibitor (MA0l)(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0l drug. If you do not know if your prescription drug contains an MA0l, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever

If pregnant or breast-feeding, as 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 [1-800-222-1222]

Directions

  • adults and children 12 years and older:

take 1 tablet 4 hours. Do not take more than 6 tablets in 24 hours

  • children under 12 years: ask a doctor

Other information

  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40. lecithin, magnesium stearate, maltrodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions?

call toll-free 1-866-933-6337

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NASAL DECONGESTANT PE   10MG
phenylphrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-204-02200 in 1 BOTTLE; Type 0: Not a Combination Product08/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/03/2021
Labeler - YYBA CORP (006339772)

Revised: 9/2021
 
YYBA CORP