Good Sense Suphedrine description, usages, side effects, indications, overdosage, supplying and lots more!

Good Sense Suphedrine

L Perrigo Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Perrigo Suphedrine 12 Hour Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
  • 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

  • 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 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 years do not use this product in children under 12 years of age
  • 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 dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Maximum Strength

Sinus

Non-Drowsy

Suphedrine 12 Hour

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

Long-Acting Nasal Decongestant

Sinus Pressure

Congestion

Pseudoephedrine HCl

(120 mg Each)

*(Capsule-Shaped Tablets)

Compare to active ingredient of Sudafed® 12 Hour Caplets

Principal Display Panel
Suphedrine 12 Hour Carton Image 1 Suphedrine 12 Hour Carton Image 2

Good Sense Suphedrine

Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0113-0054
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 120 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
COLLOIDAL SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 18 mm L054 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:0113-0054-52 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075153 1999-10-29


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Be sure to consult your doctor before taking any medication!
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