Classes
DEA Class; OTC
Common Brand Names; Tylenol Cold Multi-Symptom Severe, Tylenol Cold Head Congestion Severe, Delsym Cough + Cold Daytime, Sudafed PE Cold & Cough, Mucinex Fast-Max Cold, Flu & Sore Throat, Children’s Mucinex Multi-Symptom Cold & Fever, Children’s Mucinex Cold, Cough & Sore Throat, Tylenol Cold & Flu Severe
- Cough/Cold, Non-narcotic Combos;
- Analgesic/Antitussive/Decongestant/Expectorant Combos
Description
Oral prescription analgesic, non-opioid antitussive, expectorant and decongestant combination
Used to provide temporary relief from common cold, allergies, or flu symptoms such as mild pain, cough, nasal congestion, headache, sore throat, and fever
Indications
For the temporary relief ofcough, fever, headache, mild pain, nasal congestion, and sore throat (pharyngitis) associated with the common cold, allergic rhinitis, hay fever or other allergies; for nasal congestion associated with sinusitis or minor upper respiratory tract infections.
Contraindications
Documented hypersensitivity to any of the drugs or components
Adverse Effects
Hypertension
Reflex tachycardia
Severe peripheral and visceral vasoconstriction
Dizziness
Drowsiness
Excitability
Headache
Restlessness
Tremor
Dermatologic rash
Nausea
Vomiting
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase may increase
Warnings
Cautions
Severe or recurrent pain or high or continued fever may indicate a serious illness
Pregnancy and Lactation
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
Acetaminophen 2000 mg/day PO; dextromethorphan 120 mg/day PO; guaifenesin 2400 mg/day PO; phenylephrine 60 mg/day PO.
Acetaminophen 2000 mg/day PO; dextromethorphan 120 mg/day PO; guaifenesin 2400 mg/day PO; phenylephrine 60 mg/day PO.
Acetaminophen 2000 mg/day PO; dextromethorphan 120 mg/day PO; guaifenesin 2400 mg/day PO; phenylephrine 60 mg/day PO.
>= 12 years: Acetaminophen 2000 mg/day PO; dextromethorphan 120 mg/day PO; guaifenesin 2400 mg/day PO; phenylephrine 60 mg/day PO.
6—11 years: Acetaminophen 1000 mg/day PO; dextromethorphan 60 mg/day PO; guaifenesin 1200 mg/day PO; phenylephrine 30 mg/day PO.
< 6 years: Safety and efficacy have not been established.
