Principal Display Panel

Principal Display Panel
SPL v12
SPL
SPL Set ID e6c61658-275b-4764-8df5-9d5afc3531c5
Route
ORAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Pseudoephedrine HCl 30 mg


Medication Information

Indications and Usage

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

Dosage and Administration

adults and children 12 years and over take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use

Description

Pseudoephedrine HCl 30 mg

Section 44425-7

each tablet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Section 50565-1

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

Section 50566-9

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

Section 50567-7

do not exceed recommended dosage.

Section 50569-3

diabetes heart disease high blood pressure thyroid disease difficulty in urination due to enlargement of the prostate gland

Section 50570-1

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 51727-6

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD & C red #40 aluminum lake, FD & C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Section 51945-4

sunmark® COMPARE TO SUDAFED® SINUS CONGESTION ACTIVE INGREDIENT* NDC 70677-0005-1 nasal decongestant PSEUDOEPHEDRINE HCl 30 mg Nasal Decongestant Maximum Strength Sinus pressure Sinus congestion NON-DROWSY 24 TABLETS ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed ® Sinus Congestion. 50844     REV0619B11208 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141 ©2003 McKesson Corporation www.sunmarkbrand.com Money Back Guarantee Rev. 08/21 Sunmark 44-112

Section 53413-1

  Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Section 53414-9

ask a health professional before use.

Section 55105-1

Nasal decongestant

Section 55106-9

Pseudoephedrine HCl 30 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

adults and children 12 years and over take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use

Section 44425-7 (44425-7)

each tablet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

do not exceed recommended dosage.

Section 50569-3 (50569-3)

diabetes heart disease high blood pressure thyroid disease difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

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 51727-6 (51727-6)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD & C red #40 aluminum lake, FD & C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Section 51945-4 (51945-4)

sunmark® COMPARE TO SUDAFED® SINUS CONGESTION ACTIVE INGREDIENT* NDC 70677-0005-1 nasal decongestant PSEUDOEPHEDRINE HCl 30 mg Nasal Decongestant Maximum Strength Sinus pressure Sinus congestion NON-DROWSY 24 TABLETS ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed ® Sinus Congestion. 50844     REV0619B11208 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141 ©2003 McKesson Corporation www.sunmarkbrand.com Money Back Guarantee Rev. 08/21 Sunmark 44-112

Section 53413-1 (53413-1)

  Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Nasal decongestant

Section 55106-9 (55106-9)

Pseudoephedrine HCl 30 mg


Raw Label Data

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