Severe Allergy And Sinus Headache
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever Antihistamine Nasal decongestant
Uses
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion sneezing runny nose sinus congestion and pressure itchy, watery eyes itching of the nose or throat minor aches and pains
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: skin reddening blisters rash 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. with any other product containing diphenhydramine, even one used on skin 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 glaucoma heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages 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 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. with any other product containing diphenhydramine, even one used on skin 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 glaucoma heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease thyroid disease diabetes
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
When using this product
When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages
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
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 do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Other information
Other information see end flap for expiration date and lot number 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)
Inactive ingredients
Inactive ingredients corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin
Questions?
Questions or comments? 1-800-426-9391
Label text from the FDA structured product label by CVS Pharmacy (revised Feb 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Diphenhydramine Hydrochloride in 1 product
- Phenylephrine Hydrochloride in 1 product
Severe Allergy And Sinus Headache NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59779-543 | Acetaminophen 325 mg/1; Diphenhydramine Hydrochloride 25 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | CVS Pharmacy | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Severe Allergy And Sinus Headache used for?
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion sneezing runny nose sinus congestion and pressure itchy, watery eyes itching of the nose or throat minor aches and pains
Who makes Severe Allergy And Sinus Headache?
Severe Allergy And Sinus Headache is listed by 1 labeler in the FDA NDC directory, including CVS Pharmacy.