Publix Super Markets, Inc. Nasal Decongestant Drug Facts

Publix Super Markets, Inc. Nasal Decongestant Drug Facts

Drug Labeling and Warnings

Drug Details

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NASAL DECONGESTANT- pseudoephedrine hcl tablet, film coated 
Publix Super Markets Inc

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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Publix Super Markets, Inc. Nasal Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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

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 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 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 a fever

If pregnant or breast-feeding,

ask 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 over

  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours

children ages 6 to 11 years

  • take 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours

children under 6 years

do not use this product in children under 6 years of age

Other information

  • each tablet contains: calcium 20 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Principal Display Panel

NON-DROWSY – MAXIMUM STRENGTH

nasal decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE 30mg

nasal & sinus congestion

sinus pressure + congestion

48 TABLETS

ACTUAL SIZE

Compare to Active Ingredient in Sudafed® Congestion

Publix Nasal Decongestant image
NASAL DECONGESTANT 
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 56062-432
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScoreno score
ShapeROUND (convex) Size7mm
FlavorImprint Code L432
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 56062-432-672 in 1 CARTON10/12/2000
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 56062-432-804 in 1 CARTON04/18/2002
224 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 56062-432-621 in 1 CARTON09/09/1993
324 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/09/1993
Labeler - Publix Super Markets Inc (006922009)

Revised: 6/2018
 
Publix Super Markets Inc


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