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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 Medi-first Plus Cough Cold (NDC 47682-836). 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 Hydrobromide 10 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 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? 1-800-634-7680
Medi-First®
Cough & Cold Relief
✓ Aches, Fever • Acetaminophen 325 mg
✓ Coughs • Dextromethorphan HBr 10 mg
✓ Chest Congestion • Guaifenesin 100 mg
✓ Nasal Congestion • Phenylephrine HCl 5 mg
Pull to Open
Multi-Symptom Relief
This Package is for Households Without Young Children.
80 Caplets (40 x 2)
Tamper evident Unit Dose Packets
Medi-First® Plus
Cough & Cold Relief
Aches, Fever • Acetaminophen 325 mg
Coughs • Dextromethorphan HBr 10 mg
Chest Congestion • Guaifenesin 100 mg
Nasal Congestion • Phenylephrine HCl 5 mg
This Package is for Households Without Young Children.
Pull To Open
80 Caplets
(40 x 2's)
Relieves pain, fever, cough, and sinus pressure
Tamper Evident Unit Dose Packets
Medique®
Decorel Forte
✓ Aches, Fever • Acetaminophen 325 mg
✓ Coughs • Dextromethorphan HBr 10 mg
✓ Chest Congestion • Guaifenesin 100 mg
✓ Nasal Congestion • Phenylephrine HCl 5 mg
Severe Cold & Cough Relief
This Package is for Households Without Young Children.
Pull to Open
80 Caplets
(40 x 2)
Tamper Evident Unit Dose Packets
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