NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY- pseudoephedrine hcl tablet, film coated 
Meijer Distribution 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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Meijer Distribution, 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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® Congestion active ingredient

NON-DROWSY

MAXIMUM STRENGTH

nasal decongestant

Pseudoephedrine Hydrochloride Tablets, 30 mg

CONGESTION

96 Tablets 30 mg Each | actual size

Sinus Pressure | Congestion

Pseudoephedrine HCl

nasal decongestant image
NASAL DECONGESTANT  MAXIMUM STRENGTH NON DROWSY
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-432
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 GLYCOL (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:41250-432-6224 in 1 CARTON02/15/1991
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41250-432-6748 in 1 CARTON11/09/1995
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41250-432-8096 in 1 CARTON08/14/1997
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/15/1991
Labeler - Meijer Distribution Inc (006959555)

Revised: 1/2019
Document Id: a2e74f87-ab7f-4184-b215-e91d3ec105c5
Set id: 8a68ca99-fd76-409a-9769-88830e8720a8
Version: 4
Effective Time: 20190108
 
Meijer Distribution Inc