Sinus and Headache
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Nasal decongestant
Uses
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Warnings
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 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have high blood pressure thyroid disease liver disease diabetes heart disease difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not use
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. 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. if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use
Ask a doctor before use if you have high blood pressure thyroid disease liver disease diabetes heart disease difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
When using this product do not exceed recommended dosage.
Stop use and ask a doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Other information
Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients
Inactive ingredients corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions?
Questions or comments? 1-800-426-9391
Label text from the FDA structured product label by Cardinal Health 110, LLC. DBA Leader (revised Aug 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 11 products
- Phenylephrine Hydrochloride in 11 products
Sinus and Headache NDC products (11)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 57344-923 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | AAA Pharmaceutical, Inc. | OTC MONOGRAPH DRUG |
| 70000-0568 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Cardinal Health 110, LLC. DBA Leader | OTC MONOGRAPH DRUG |
| 53943-323 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | DISCOUNT DRUG MART | OTC MONOGRAPH DRUG |
| 55910-466 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | DOLGENCORP, LLC | OTC MONOGRAPH DRUG |
| 55319-496 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Family Dollar Services Inc | OTC MONOGRAPH DRUG |
| 50804-123 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | GOODSENSE | OTC MONOGRAPH DRUG |
| 42507-223 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | HYVEE INC | OTC MONOGRAPH DRUG |
| 50844-467 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | L.N.K. International, Inc. | OTC MONOGRAPH DRUG |
| 72476-123 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | RETAIL BUSINESS SERVICES , LLC. | OTC MONOGRAPH DRUG |
| 11822-4669 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Rite Aid Corporation | OTC MONOGRAPH DRUG |
| 0363-4066 | Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Walgreen Company | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Sinus and Headache used for?
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Who makes Sinus and Headache?
Sinus and Headache is listed by 11 labelers in the FDA NDC directory, including AAA Pharmaceutical, Inc., Cardinal Health 110, LLC. DBA Leader, DISCOUNT DRUG MART, DOLGENCORP, LLC.