Adult Dosing
Temporary relief of cold/flu symptoms
- Mucinex Fast-Max Cold, Flu & Sore Throat
- LIQ: 20 mL PO q4 hrs PRN
- Max: 120 mL/day
- Sine-Off Cold/Cough
- 2 tabs PO tid-qid PRN
- Max: 8 tabs/day
- Sudafed PE Cold + Cough, Tylenol Cold Head Congestion Severe
- 2 tabs PO q4 hrs PRN
- Max: 12 tabs/day
- Tylenol Cold Multi-Symptom Severe
- 2 tabs PO q4 hrs PRN
- Max: 12 tabs/day
- 2 tablespoons or 30 mL PO q4 hrs
- Max: 12 tablespoons or 180 mL/day
- Tylenol Cough & Severe Congestion Daytime
- LIQ: 30 mL PO q4 hrs PRN
- Max: 180 mL/day
Pediatric Dosing
Temporary relief of cold/flu symptoms
- Children's Mucinex Cold, Cough & Sore Throat (6-11 yrs)
- LIQ: 10 mL PO q4 hrs PRN
- Max: 5 doses/day
- Children's Mucinex Multi-Symptom Cold & Fever (6-11 yrs)
- LIQ: 10 mL PO q4 hrs PRN
- Max: 5 doses/day
- Mucinex Fast-Max Cold, Flu & Sore Throat (>12 yrs)
- LIQ: 20 mL PO q4 hrs PRN
- Max: 120 mL/day
- Sine-Off Cold/Cough (>12 yrs)
- 2 tabs PO tid-qid PRN
- Max: 8 tabs/day
- Sudafed PE Cold + Cough, Tylenol Cold Head Congestion Severe (>12 yrs)
- 2 tabs PO q4 hrs PRN
- Max: 12 tabs/day
- Tylenol Cold Multi-Symptom Severe (>12 yrs)
- 2 tabs PO q4 hrs PRN
- Max: 12 tabs/day
- 2 tablespoons or 30 mL PO q4 hrs
- Max: 12 tablespoons or 180 mL/day
- Tylenol Cough & Severe Congestion Daytime (>12 yrs)
- LIQ: 30 mL PO q4 hrs PRN
- Max: 180 mL/day
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Acetaminophen
- 10-50 mL/min: give q6 hrs
- <10 (mL/min): give q8 hrs
- Dextromethorphan/guaifenesin/phenylephrine
- Renal impairment: Dose adjustments not defined
Hepatic Dose Adjustment
- Acetaminophen
- Hepatic impairment: Consider dose reduction; dose adjustments not defined
- Dextromethorphan/guaifenesin/phenylephrine
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Overdosage of this product may cause severe liver damage, which may occur on exceeding recommended dosages, concomitant use with other drugs containing acetaminophen, or on consuming 3 or more alcoholic drinks every day while receiving therapy. Avoid concomitant use with any other drugs containing acetaminophen
- Discontinue therapy if sore throat becomes severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting; further evaluate the patient and provide appropriate therapy
- Discontinue therapy and consult a clinician if new symptoms occur, redness or swelling is noted, pain/cough/nasal congestion gets worse or lasts more than 7 days, fever gets worse or lasts >3 days; nervousness, dizziness or sleeplessness occurs, or if cough comes back or occurs with rash or headache that lasts; further evaluate patients as these could be signs of a serious condition
- Dizziness, drowsiness, or blurred vision may occur with this drug; concomitant use of other sedatives and tranquilizers and alcohol abuse worsen these effects. Hence, avoid use of these drugs and advise patients to avoid alcohol during therapy
- Use only enclosed dosing cup provided with this product; avoid using any other dosing device
- Drink plenty fluids to help loosen the congestion and lubricate throat during therapy
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Cardiac disease
- Hypertension
- Arrhythmias
- Hyperthyroidism
- Diabetes mellitus
- Prostatic hypertrophy
- Cough with excessive phlegm
- Chronic cough
- Asthma
- Angle-closure glaucoma
- Chronic alcohol use
- Anticoagulant use
- CNS depressant use
- Severe hypovolemia
- Chronic malnutrition
- PKU (phenylalanine-containing forms)
- Nephrolithiasis
Supplemental Patient Information
- Advise patients to avoid driving a motor vehicle or operating machinery, as drowsiness may occur during therapy
- Advise patients to consult their physician if symptoms do not improve in 7 days, if new symptoms occur, or if fever gets worse or lasts more than 3 days
- Instruct patients to avoid alcoholic beverages during therapy
Pregnancy Category:B (acetaminophen), C (dextromethorphan), C (guaifenesin), C (phenylephrine)
Breastfeeding: Acetaminophen is a good choice for analgesia and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 May 2011). Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 11 May 2011).No studies conducted on the excretion of dextromethorphan in milk or its effect on breastfed infants. However, this medication can be administered to infants as young as 1 month of age. It is unlikely that with usual maternal doses amounts in milk are as large as those given directly to infants or that breastfed infants would be harmed by the drug in breastmilk, especially in infants over 1 month of age. Avoid the use of products with a high alcohol content while nursing. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 May 2011). No studies have been conducted on excretion of guaifenesin in milk or its effect on breastfed infants. This medication can be given to infants as young as 2 month of age; it is unlikely that usual maternal doses amounts in milk are as large as those given directly to infants and would harm the breastfed infants, especially in infants over 2 months of age. Avoid the use of products with a high alcohol content while nursing. This information is based on based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 May 2011).Phenylephrine is unlikely to reach the infant in large amounts, as the oral bioavailability of phenylephrine is only about 40%. However, oral administration of phenylephrine decreases milk production. As no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 May 2011). Manufacturer advises to consult a health professional.
US Trade Name(s)
- Children's Mucinex Cold
- Cough & Sore Throat
- Children's Mucinex Multi-Symptom Cold & Fever
- Mucinex Fast-Max Cold
- Flu & Sore Throat
- Sine-Off Cold/Cough
- Sudafed PE Cold + Cough
- Tylenol Cold Head Congestion Severe
- Tylenol Cold Multi-Symptom Severe
- Tylenol Cough & Severe Congestion Daytime
US Availability
Children's Mucinex Cold, Cough & Sore Throat (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- LIQ: [325 mg/10 mg/200 mg/5 mg]/10 mL
Children's Mucinex Multi-Symptom Cold & Fever (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- LIQ: [325 mg/10 mg/200 mg/5 mg]/10 mL
Mucinex Fast-Max Cold, Flu & Sore Throat
- LIQ: [650 mg/20 mg/400 mg/10 mg]/20 mL
Sine-Off Cold/Cough (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- TABS: 325 mg/15 mg/200 mg/5 mg
Sudafed PE Cold + Cough (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- TABS: 325 mg/10 mg/100 mg/5 mg
Tylenol Cold Head Congestion Severe (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- TABS: 325 mg/10 mg/200 mg/5 mg
Tylenol Cold Multi-Symptom Severe (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- LIQ: [325 mg/10 mg/200 mg/5 mg]/15 mL
- TABS: 325 mg/10 mg/200 mg/5 mg
Tylenol Cough & Severe Congestion Daytime (acetaminophen/dextromethorphan/guaifenesin/phenylephrine)
- LIQ: [325 mg/10 mg/200 mg/5 mg]/15 mL
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]