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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medique At Home Decorel Forte (NDC 47682-735). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
Temporarily relieves these symptoms due to the common cold:
Temporarily reduces fever.
Warnings
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.
Do not use
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
Stop use and ask a doctor if
These could be signs of a serious condition.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product do not exceed recommended dosage.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
Directions
Adults and children: (12 years and over):
Children under 12 years: ask a doctor
Other information
Inactive ingredients
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
Questions or comments? 1-800-634-7680
Medique® @ Home
Decorel Forte
Acetaminophen 325 mg •
Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg •
Cough Suppressant
Guaifenesin 100 mg •
Expectorant
Phenylephrine HCl 5 mg •
Nasal Decongestant
Pull to Open
Child-Resistant Packets
*not actual size
50 Packets
(2 Caplets Per Packet)
* Please review the disclaimer below.