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SudoGest (pseudoephedrine hydrochloride 120 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Major Pharmaceuticals

Generic: pseudoephedrine hydrochloride

SudoGest tablet, film coated, extended release - (pseudoephedrine hydrochloride 120 mg) image
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IMPRINT: 204     SHAPE: oval
    COLOR: white

All Imprints

pseudoephedrine hydrochloride 120 mg - 204 oval white

12 hr pseudoephedrine hydrochloride 120 mg extended release oral tablet [sudogest] - 204 oval white

pseudoephedrine hydrochloride 120 mg - 204 capsule white

  1. FDA Adverse Reactions

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Active Ingredient (in Each Tablet)


Pseudoephedrine HCl USP, 120 mg

Purpose


Nasal decongestant

Uses


temporarily relieves nasal congestion due to:
  • •common cold
  • •hay fever
  • •upper respiratory allergies
  • •temporarily restores freer breathing through the nose
  • •promotes nasal and/or sinus drainage
  • •temporarily relieves sinus congestion and pressure

Warnings


Do not use


if you are 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
  • •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

  • •symptoms do not get better within 7 days or occur with a fever
  • •you get nervous, dizzy, or sleepless

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 and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • •children under 12 years: ask a doctor

Other Information

  • •store at 59° to 77° F in a dry place
  • •protect from light
  • • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients


castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?


call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

LIVONIA, MI 48150, USA

Principal Display Panel


MAJOR ®

NDC 0904-5803-15

SudoGest 12 HOUR

Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg

LONG-ACTING NASAL DECONGESTANT

RELIEVES:
  • • NASAL & SINUS CONGESTION DUE TO COLDS & ALLERGIES
  • • SINUS PRESSURE

MAXIMUM STRENGTH

NON-DROWSY

10 COATED CAPLETS *

(120 mg EACH)

* Capsule-Shaped Tablets

COMPARE TO the active ingredient of SUDAFED ® 12 HOUR **

** This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED ® 12 Hour.

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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