12 hour decongestant description, usages, side effects, indications, overdosage, supplying and lots more!

12 hour decongestant

Kroger 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
Kroger Co. 12 Hour Decongestant 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

take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours

    adults and children 12 years and over

    children under 12 years

    do not use this product in children under 12 years of age

    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 dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

    Questions or comments?

    1-800-632-6900

    Principal Display Panel

    COMPARE TO the active ingredient of SUDAFED® 12 HOUR CAPLETS

    NON-DROWSY

    SINUS

    12 Hour Decongestant

    Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

    Long-Acting Nasal Decongestant

    MAXIMUM STRENGTH

    Sinus Pressure

    Congestion

    Pseudoephedrine HCl

    20 COATED CAPLETS*

    120 mg EACH

    *Capsule-Shaped Tablets

    actual size

    12 hour decongestant

    Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:30142-054
    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
    SILICON DIOXIDE
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
    HYPROMELLOSES
    MAGNESIUM STEARATE
    cellulose, microcrystalline
    POLYETHYLENE GLYCOLS
    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 1 in 1 BLISTER PACK
    2 NDC:30142-054-60 20 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075153 1999-12-14


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