Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Severe Cold And Cough Relief (NDC 49580-0501). 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 30 ml), purposes, 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 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Cough suppressant
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 inclide:
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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
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Compare to active ingredients of Theraflu® ExpressMax® Daytime Severe Cold & Cough*
adult day time
severe cold & cough relief
Acetaminophen 650 mg
pain reliever/fever reducer
dextromethorphan HBr 20 mg
cough suppressant
Phenylephrine HCI 10 mg
nasal decongestion
relieves:
for ages 12 years & over
alcohol 10%
Berry Flavor
fl oz (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
* Please review the disclaimer below.