Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Sedalmex Xl Flu (NDC 27854-350). 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
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
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.
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.
do not exceed recommended dosage.
ask a health professional before use.
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.
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
1-888-779-2877
NDC 27854-350-01
Bellmora LLC
SEDALMEX XL
flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
NON-DROWSY
24 CAPLETS
Actual Size
Relieves: Fever, Headache, Cough, Sore
Throat, Sinus Pressure & Chest Congestion
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Questions or Comments Call.
1-888-779-2877 M-F 9AM-5PM EST
Distributed by Belmora LLC, 3033 Wilson Blvd.
Suite 700, Arlington, VA 22201
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