Suphedrine

pseudoephedrine hydrochloride

Dosage Form: tablet, film coated, extended release
Rite Aid Corporation Suphedrine Tablets Drug Facts

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?

1-800-719-9260

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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  pseudoephedrine hydrochloride  tablet, film coated, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11822-0054 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code L054 Contains

Packaging # NDC Package Description Multilevel Packaging 1 11822-0054-6 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11822-0054-6)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075153	08/13/2002

Labeler - Rite Aid Corporation (014578892)

Revised: 08/2009Rite Aid Corporation

More Suphedrine resources

• Suphedrine Side Effects (in more detail)
• Suphedrine Use in Pregnancy & Breastfeeding
• Suphedrine Drug Interactions
• Suphedrine Support Group
• 0 Reviews for Suphedrine - Add your own review/rating

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