First Aid Direct Nasal and Sinus Decongestant
- Manufacturer
- Cintas Corporation | Allegiant Health
- Effective date
- 2024-12-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:44:19
Label at a glance#
ProductFirst Aid Direct Nasal and Sinus Decongestant
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
WARNINGS SECTION
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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 12 years and over:
- 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
Children under 12 years: ask a doctor
OTHER SAFETY INFORMATION
Other information
- store at room temperature 20°-25°C (68°-77°F)
- do not use if packet is opened or torn
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-800-327-2704 M-F 8AM-5PM
Principal Display Panel - 25 CT Box
NASAL & SINUS DECONGESTANT
- Compare to active ingredients in SUDAFED PE® Sinus Congestion*
- Helps to temporarily relieve: sinus congestion and pressure, nasal congestion due to the common cold, hay fever or other upper respiratory allergies
25 Tablets • 1 Tablet per Packet
NASAL & SINUS DECONGESTANT
Active Ingredient:
Phenylephrine HCl 10 mg
- Compare to active ingredients in SUDAFED PE® Sinus Congestion*
- Aspirin-free formula
25 Tablet • 1 Tablet per Packet
Product #112350
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- First Aid Direct Nasal and Sinus Decongestant
- Phenylephrine HCl
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- LACTOSE, UNSPECIFIED FORM
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42961-125 | 42961-125-01, 42961-125-02 |
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 |
|---|---|---|---|---|---|---|
| 8bf80b4f-e045-4773-91e4-69dff3f73965 | 8d8d054c-0d62-4c85-b3e1-c66db9073ef2 | 2025-07-28 | Warnings | 8d8d054c-0d62-4c85-b3e1-c66db9073ef2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.