Your browser does not support JavaScript! EQUATE SUPHEDRINE (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WAL-MART STORES INC]
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EQUATE SUPHEDRINE (pseudoephedrine hydrochloride) tablet, film coated, extended release
[Wal-Mart Stores Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

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

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

  • high blood pressure
  • heart disease
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

When using this product

  • do not use more than directed

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

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.

Directions

  • adults and children 12 years of age and over: one tablet every 12 hours not to exceed two tablets in 24 hours
  • children under 12 years of age: use of product not recommended

Other information

  • each tablet contains: calcium 45 mg
  • store at 20° - 25°C (68° - 77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to Sudafed® 12 Hour Active Ingredient

Non-Drowsy

Suphedrine

Pseudoephedrine Hydrochloride Extended-Release Tablets 120 mg

12 HOUR

Long-Acting Nasal Decongestant

12 HOUR

Relieves:

Nasal and sinus congestion due to colds and allergies

Sinus pressure

*Capsule-Shaped Tablets

120 mg EACH

Actual Size

Suphedrine Carton Image 1

Suphedrine Carton Image 1

Suphedrine Carton Image 2

Suphedrine Carton Image 2

EQUATE SUPHEDRINE 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-054
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
COLLOIDAL SILICON DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code L054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-054-602 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515307/19/2000
Labeler - Wal-Mart Stores Inc (051957769)

Revised: 11/2011
 
Wal-Mart Stores Inc

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