Indications and uses
• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Maximum Strength Nasal Decongestant
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:12
Label at a glance#
ProductMaximum Strength Nasal Decongestant
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
adults & children12 years & over • take 1 tablet every 4 hours • do not take more than 6 tablets in 24 hours children under 12 years ask a doctor
Storage and handling
• store between 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Phenylephrine Hydrochloride 10 mg
Purpose
Nasal decongestant
Uses
• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose
OTC - STOP USE SECTION
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| adults & children12 years & over | • take 1 tablet every 4 hours • do not take more than 6 tablets in 24 hours |
| children under 12 years | ask a doctor |
Other information
• store between 20-25°C (68-77°F)
Inactive ingredients
Carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, *contains one or more of these ingredients
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Made in India
Carton
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-5011-7 | Maximum Strength Nasal Decongestant | 3 in 1 CARTON | TABLET, COATED | 3 | 4 | |
| 68210-5011-7 | Maximum Strength Nasal Decongestant | 24 in 1 BLISTER PACK | TABLET, COATED | 24 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-5011 | MAXIMUM STRENGTH NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SPIRIT PHARMACEUTICALS LLC] | 4 | 2 package rows | 20241215_4e1621cb-5c72-4ebb-a331-e96005dffbc0.zip |
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Nasal Decongestant
- Phenylephrine Hydrochloride
- CARNAUBA WAX
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10 ALUMINUM LAKE
- CALCIUM PHOSPHATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSES
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A
- STARCH, POTATO
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-5011 | 68210-5011-7 |
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 |
|---|---|---|---|---|---|---|
| 292d82d4-ad6c-635a-e063-6294a90a641f | 4e1621cb-5c72-4ebb-a331-e96005dffbc0 | 2024-12-13 | Warnings | 292d82d4-ad6c-635a-e063-6294a90a641f 4e1621cb-5c72-4ebb-a331-e96005dffbc0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.