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SudoGest

Major Pharmaceuticals, Inc
Silarx Pharmaceuticals, Inc

SudoGest Children's Syrup


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)                         Purpose

Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant

Uses

Uses

  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • promotes nasal and/or sinus drainage

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
  • a sodium restricted diet

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 occur with fever

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

  • Take at every 6 hours, if needed
  • Do not exceed 4 doses in 24 hours.

Adults and children 12 years of age and over
4 teaspoonfuls (tsp)
Children 6 to under 12 years of age
2 teaspoonfuls (tsp)
Children under 6 years of age DO NOT USE
Other information


Inactive ingredients

citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

Questions? Serious Adverse Effects call:

800-616-2471

†Major SudoGest is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Sudafed® Nasal Decongestant.

Distributed by:

Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA


SudoGest
SudoGest



SudoGest

Pseudoephedrine hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5367
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
saccharin sodium
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5367-20 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2001-01-05


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Be sure to consult your doctor before taking any medication!
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