Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Pain, Headache And Cough (NDC 51316-803). 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, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Pain reliever/fever reducer
Cough suppressant
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.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
taking the blood thinning drug warfarin.
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, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
1-800-426-9391
NDC 51316-803-09
♥CVS™
actual size
Maximum Strength†
PAIN, HEADACHE & COUGH
Acetaminophen, Pain Reliever / Fever Reducer
Dextromethorphan HBr, Cough Suppressant
Compare to Maximum Strength Mucinex® Rapid+Clear™
Pain, Headache & Cough active ingredients*
20
CAPLETS
Relieves: Pain & Headache,
Reduces Fever, Controls Cough
†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
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*This product is not manufactured or distributed by RB Health
(US) LLC, owner of the registered trademark Maximum Strength
Mucinex® Rapid+Clear™ Pain, Headache & Cough.
50844 ORG022680309
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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