Pseudoephedrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Pseudoephedrine Hydrochloride

Premier Value
Ohm Laboratories Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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
  • 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

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value ®

NDC 68016-204-69

Pseudoephedrine HCl Extended-Release Tablets USP, 120 mg

Sinus & Allergy

Long-Acting Nasal Decongestant

Non-Drowsy

12 Hour

  • Nasal & Sinus Congestion due to Colds & Allergies
  • Sinus Pressure
  • Maximum Strength

10 Coated Capsule-Shaped Tablets 120 mg Each

Compare to the active ingredient in Sudafed ® 12 Hour

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

Pseudoephedrine Hydrochloride

Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-204
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
castor oil
COLLOIDAL SILICON DIOXIDE
HYPROMELLOSES
cellulose, microcrystalline
MAGNESIUM STEARATE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 18 mm 204 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-204-69 10 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077442 2006-04-28


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Be sure to consult your doctor before taking any medication!
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