Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Severe Allergy And Sinus Headache (NDC 59779-543). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
Pain reliever
Antihistamine
Nasal decongestant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
1-800-426-9391
♥ CVS Health™
Caplets
NDC 59779-543-09
MAXIMUM STRENGTH
Severe Allergy
& Sinus Headache
ACETAMINOPHEN, DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl
Pain reliever, Antihistamine
Nasal decongestant
For Allergy Plus Sinus Pain
& Pressure Relief of:
Sneezing, Runny nose, Sinus headache,
Sinus congestion, Sinus pain & pressure,
Itchy, watery eyes
20 CAPLETS
Capsule-Shaped Tablets
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
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One CVS Drive, Woonsocket, RI 02895
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