Active Ingredients And Purpose
Active Ingredient (in each tablet)
Phenylephrine Hydrochloride 10 mg
Purpose
Nasal decongestant
Maximum Strength Nasal Decongestant
- Set ID
- 4e1621cb-5c72-4ebb-a331-e96005dffbc0
- 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
Products
- Maximum Strength Nasal Decongestant
- PHENYLEPHRINE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| D&C YELLOW NO. 10 ALUMINUM LAKE | CQ3XH3DET6 | IACT |
| CALCIUM PHOSPHATE | 97Z1WI3NDX | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| STARCH, POTATO | 8I089SAH3T | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
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
Carton
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/4e1621cb-5c72-4ebb-a331-e96005dffbc0/292d82d4-ad6c-635a-e063-6294a90a641f.xml
- XML SHA-256
- 4b0b90ee12ef0517c505a9a8b96791a55f7998b852e3886bbd7aba45e39f0740
- XML bytes
- 27298
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 292d82d4-ad6c-635a-e063-6294a90a641f.xml | 2024-12-15 |
| otc | 0c046878-f130-29b5-e063-6394a90a2828.xml | 2023-12-09 |
| otc | f45fb1c8-d821-4029-e053-2995a90aeb26.xml | 2023-02-12 |
| otc | Nasal Decongestant 72 ct.jpg | 2023-02-12 |