Label: EQUATE SUPHEDRINE- pseudoephedrine hydrochloride tablet, film coated, extended release
- NDC Code(s): 49035-054-60
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient (in each tablet)
Pseudoephedrine HCl 120 mgClose
- 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
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
- thyroid disease
- trouble urinating due to an enlarged prostate gland
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Sudafed® 12 Hour Active Ingredient
Pseudoephedrine Hydrochloride Extended-Release Tablets 120 mg
Long-Acting Nasal Decongestant
Nasal and sinus congestion due to colds and allergies
120 mg EACH
Suphedrine Carton Image 1
Suphedrine Carton Image 2
- INGREDIENTS AND APPEARANCE
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-054 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code L054 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-054-60 2 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075153 07/19/2000 Labeler - Wal-Mart Stores Inc (051957769)