Pseudoephedrine Hydrochloride

Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (120 mg)

Inactive Ingredients

Castor Oil Silicon Dioxide Hypromellose, Unspecified Microcrystalline Cellulose Magnesium Stearate Titanium Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2021-02-19

Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product do not exceed recommended dosage

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

adults and children 12 years and over	take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Questions?

1-800-632-6900

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

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl, USP 120 mg

Ask A Doctor Before Use If You Have

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

Principal Display Panel 120 Mg Blister Pack Carton

COMPARE TO the active ingredient of

SUDAFED^® 12 HOUR _{**See side panel}

NDC 30142-967-20

Kroger_®

OUR PHARMACIST RECOMMENDED

Maximum Strength

Sinus

Pseudoephedrine Hydrochloride 120 mg

12 Hour Extended-Release Tablets, USP

LONG ACTING

NASAL DECONGESTANT

NON-DROWSY

Relieves Sinus

Pressure + Congestion

actual

size

12

HOUR

20 COATED

CAPLETS*

120 mg EACH

*capsule-shaped tablets

Structured Label Content

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nasal decongestant

Directions

adults and children 12 years and over	take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Questions?

1-800-632-6900

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Principal Display Panel 120 Mg Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton)

COMPARE TO the active ingredient of

SUDAFED^® 12 HOUR _{**See side panel}

NDC 30142-967-20

Kroger_®

OUR PHARMACIST RECOMMENDED

Maximum Strength

Sinus

Pseudoephedrine Hydrochloride 120 mg

12 Hour Extended-Release Tablets, USP

LONG ACTING

NASAL DECONGESTANT

NON-DROWSY

Relieves Sinus

Pressure + Congestion

actual

size

12

HOUR

20 COATED

CAPLETS*

120 mg EACH

*capsule-shaped tablets

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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "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 the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure", "42229-5": "Drug Facts", "50565-1": "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)", "50567-7": "When using this product do not exceed recommended dosage", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nasal decongestant", "Directions": "adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age", "Questions?": "1-800-632-6900", "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", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "Active ingredient (in each tablet)": "Pseudoephedrine HCl, USP 120 mg", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland", "PRINCIPAL DISPLAY PANEL - 120 mg Blister Pack Carton": "COMPARE TO the active ingredient of SUDAFED ® 12 HOUR **See side panel NDC 30142-967-20 Kroger ® OUR PHARMACIST RECOMMENDED Maximum Strength Sinus Pseudoephedrine Hydrochloride 120 mg 12 Hour Extended-Release Tablets, USP LONG ACTING NASAL DECONGESTANT NON-DROWSY Relieves Sinus Pressure + Congestion actual size 12 HOUR 20 COATED CAPLETS* 120 mg EACH *capsule-shaped tablets"}

Pseudoephedrine Hydrochloride

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information