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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 Multi-symptom Cold Relief (NDC 47682-047). 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
Ask a doctor before use if you have
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.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
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? 1-800-869-6970
Multi-Symptom Cold Relief™
Pull to Open
Tire Para Abrir
Acetaminophen / Acetaminofeno 325 mg
Dextromethorphan HBr / Hidrobromuro de dextrometorfano 10 mg
Guaifenesin / Guaifenesina 100 mg
Phenylephrine HCl / Hidrocloruro de fenilefrina 5 mg
Green Guard®
Pain reliever/Fever reducer
Multi-Symptom Relief
Alivia el dolor/Reduce la fiebre
Alivia multisintomas
Distributed by Green Guard®
St Louis, MO 63045
40 Packets of 2 Caplets
80 Caplets
Order #2580
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