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Suphedrine Prescribing Information

Package insert / product label
Generic name: pseudoephedrine hydrochloride
Dosage form: tablet, film coated, extended release
Drug class: Decongestants

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Indications and Usage for Suphedrine

  • 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.

Suphedrine Dosage and Administration

  • 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

Storage and Handling

  • 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?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Sudafed® 12 Hour

Relieves: Nasal & Sinus Congestion due to Colds & Allergies without drowsiness

Suphedrine

Pseudoephedrine Hydrochloride Extended-Release Tablets 120 mg

12 Hour Long-Acting Nasal Decongestant

Maximum Strength

*Capsule-Shaped Tablets


Suphedrine Tablets Carton

Suphedrine Tablets Carton

SUPHEDRINE
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0054
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeL054
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0054-62 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515308/13/2002
Labeler - Rite Aid Corporation (014578892)

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