First Aid Direct Headache and Congestion Sinus Relief
- Manufacturer
- Cintas Corporation | Allegiant Health
- Effective date
- 2025-09-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:34:25
Label at a glance#
ProductFirst Aid Direct Headache and Congestion Sinus Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet)
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion
- promotes sinus drainage
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor before use if you are taking the blood thining drug warfarin.
OTC - STOP USE SECTION
Stop use and ask doctor if
- nervousness, dizziness, or sleplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- adults and children 12 years and older: • take 2 tablets every 6 hours • do not take more than 8 tablets in 24 hours
- children under 12 years of age: ask a doctor
OTHER SAFETY INFORMATION
Other information
- store at room temperature between 20-25°C (68-77°F)
- do not use if packet is open or torn
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
OTC - QUESTIONS SECTION
Questions?
Call 1-800-327-2704 M-F 8AM-5PM
Principal Display Panel - 42961-126-02
HEADACHE & CONGESTION
SINUS RELIEF
Active Ingredients:
Acetaminophen • Phenylephrine HCl
Pain Reliever/Fever Reducer & Nasal Decongestant
- Fast acting relief for nasal and sinus congestion
- Helps reduce sinus pain, pressure, fever, and pain
50 Tablets • 25 Packets (2 Tablets in each packet) per Box
Products#
Every source-derived product name is available through these pages.
- First Aid Direct Headache and Congestion Sinus Relief
- Acetaminophen Phenylephrine HCl
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- STARCH, CORN
- CROSPOVIDONE
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42961-126 | 42961-126-01, 42961-126-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| 80b6e06d-f1da-4c39-b231-13d4db4a58e8 | a518e124-5a96-4a08-9b5f-3eaa8bf944c0 | 2026-05-21 | Warnings | a518e124-5a96-4a08-9b5f-3eaa8bf944c0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.