Indications and uses
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure
nasal decongestant
- Manufacturer
- Strategic Sourcing Services, LLC (Health Mart) | LNK International, Inc.
- Effective date
- 2025-04-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:39:48
Label at a glance#
Productnasal decongestant non-drowsy
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections
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
Storage and handling
each tablet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.mckesson.com
www.mckesson.com
www.mckesson.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Pseudoephedrine HCl 30 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
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the 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 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 (1-800-222-1222) right away.
Directions
| 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 |
Other information
- each tablet contains: calcium 15 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
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
Questions or comments?
1-800-426-9391
Principal display panel
Health Mart®
NDC 62011-0312-3
Compare to Sudafed®
Sinus Congestion
active ingredient*
Nasal
Decongestant
Pseudoephedrine HCl 30 mg
Nasal Decongestant
Relieves Nasal & Sinus Congestion/Sinus Pressure
Non-Drowsy
Actual Size
96 Tablets
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® Congestion.
50844 REV0619B11246
Mckesson
Distributed by McKesson Corporation
6555 State Highway 161
Irving, TX 75039www.mckesson.com
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62011-0312 | NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES, LLC (HEALTH MART)] | 14 | Legacy NDC | 20250411_37d70b85-a519-441d-9b33-784684f55dbc.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62011-0312-1 | EA - Each | 62011-0312 | 2e7b187b-aafd-4667-a699-9504abb404e7 | 1 | 2017-06-15 |
| 62011-0312-2 | EA - Each | 62011-0312 | 111fc884-d087-4983-b5a7-326a1f86016c | 1 | 2017-11-06 |
| 62011-0312-3 | EA - Each | 62011-0312 | b29fce1b-ca79-495a-9f6c-8d19acccc3ac | 1 | 2017-11-06 |
Products#
Every source-derived product name is available through these pages.
- nasal decongestant non-drowsy
- Pseudoephedrine HCl
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- CROSCARMELLOSE SODIUM
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
- TITANIUM DIOXIDE
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62011-0312 | 62011-0312-1, 62011-0312-2, 62011-0312-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 925f4d90-9dd2-40b7-8f0a-b2e74ba43f08 | 37d70b85-a519-441d-9b33-784684f55dbc | 2025-04-10 | Warnings | 925f4d90-9dd2-40b7-8f0a-b2e74ba43f08 37d70b85-a519-441d-9b33-784684f55dbc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.