Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Allergy And Headache (NDC 51316-561). 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
Pain reliever
Antihistamine
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 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.
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone K30, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide, triacetin
1-800-426-9391
♥︎CVS™
NDC 51316-561-09
actual size
Maximum Strength†
ALLERGY &
HEADACHE
Acetaminophen, Pain Reliever
Diphenhydramine HCl, Antihistamine
20
CAPLETS
Relief of:
Headache, Sneezing, Runny nose,
Itchy throat & Itchy, watery eyes
†Under OTC monograph.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING
50844 ORG072551609
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
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