Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure8 sections
Indications and uses
temporarily relieves these common cold and flu symptoms: sinus congestion and pressure minor aches and pains nasal congestion cough due to minor throat and bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and administration
do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL=milliliter tsp=teaspoonful Age.............................. Dose Adults and children 12 years of age and older 20 mL in dosing cup provided every 4 hours Children under 12 years of age...
Storage and handling
each 10 mL contains: sodium 10mg store between 20-25°C (68-77°F) do not refrigerate keep carton for complete Drug Facts
temporarily relieves these common cold and flu symptoms:
sinus congestion and pressure
minor aches and pains
nasal congestion
cough due to minor throat and bronchial irritation
sore throat
headache
temporarily reduces fever
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
WARNINGS SECTION
Liver warning
SPL UNCLASSIFIED SECTION
This product contains acetaminophen.
Severe liver damage may occur if you take:
more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product
Allergy allert
SPL UNCLASSIFIED SECTION
Acetaminophen may cause severe skin reactions.
Symptoms may include:
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning
SPL UNCLASSIFIED SECTION
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
OTC - DO NOT USE SECTION
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
for children under 12 years of age
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´s disease), or for 2 weeks after stopping the MAOI drug. 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
OTC - ASK DOCTOR SECTION
liver disease
heart disease
diabetes
thyroid disease
high blood pressure
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking the blood thinning drug warfarin, taking sodium restricted diet.
Stop use and ask a doctor if
OTC - STOP USE SECTION
nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back, or occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask health professional before use
Keep out of reach of children
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Overdose warning
SPL UNCLASSIFIED SECTION
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
DOSAGE & ADMINISTRATION SECTION
do not take more than directed (see Overdose warning)
do not take more than 6 doses in any 24 hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
mL=milliliter
tsp=teaspoonful
Age.............................. Dose
Adults and children 12 years of age and older 20 mL in dosing cup provided every 4 hours
Children under 12 years of age do not use
Other information
STORAGE AND HANDLING SECTION
each 10 mL contains:
sodium 10mg
store between 20-25°C (68-77°F)
do not refrigerate
keep carton for complete Drug Facts
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