Active Ingredients And Purpose
Active Ingredient (in each tablet)
Phenylephrine Hydrochloride 10 mg
Purpose
Nasal decongestant
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
Key Label Information#
Uses
Uses
• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings
Warnings
Directions And Dosage
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 Label Information
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
Carton
Label Images#
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#
- Maximum Strength Nasal Decongestant
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-5011 | 68210-5011-7 |
Ingredients#
Complete SPL Sections#
Drug Facts
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
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