Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (120 mg)

Inactive Ingredients

Castor Oil Colloidal Silicon Dioxide Hypromelloses Cellulose, Microcrystalline Magnesium Stearate Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 204 Shape: capsule Color: white Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2006-04-28

Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl USP, 120 mg

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

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

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.

Questions?

Call 1-800-406-7984

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

Principal Display Panel

SHOPKO ^®

Compare to the active ingredient of SUDAFED ^® 12 Hour

12 Hour, Non-Drowsy

Nasal Decongestant

Pseudoephedrine HCl Extended-Release Tablets, USP 120 mg

Long-Acting Nasal Decongestant

Nasal & Sinus Congestion Due to Colds & Allergies

Sinus Pressure

Maximum Strength

Manufactured by: Ohm Laboratories Inc.

5089484/R0212

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.

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl USP, 120 mg

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses (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

Purpose (PURPOSE)

Nasal decongestant

Directions (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

Do Not Use (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.

Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (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 (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SHOPKO ^®

Compare to the active ingredient of SUDAFED ^® 12 Hour

12 Hour, Non-Drowsy

Nasal Decongestant

Pseudoephedrine HCl Extended-Release Tablets, USP 120 mg

Long-Acting Nasal Decongestant

Nasal & Sinus Congestion Due to Colds & Allergies

Sinus Pressure

Maximum Strength

Manufactured by: Ohm Laboratories Inc.

5089484/R0212

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

Ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Pseudoephedrine HCl USP, 120 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
high blood pressure
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

[{"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COLLOIDAL SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "PURPOSE": "Nasal decongestant", "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", "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.", "QUESTIONS?": "Call 1-800-406-7984", "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", "PRINCIPAL DISPLAY PANEL": "SHOPKO ® Compare to the active ingredient of SUDAFED ® 12 Hour 12 Hour, Non-Drowsy Nasal Decongestant Pseudoephedrine HCl Extended-Release Tablets, USP 120 mg Long-Acting Nasal Decongestant Nasal & Sinus Congestion Due to Colds & Allergies Sinus Pressure Maximum Strength Manufactured by: Ohm Laboratories Inc. 5089484/R0212", "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.", "ACTIVE INGREDIENT (IN EACH TABLET)": "Pseudoephedrine HCl USP, 120 mg", "Ask a doctor before use if you have": "heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information