Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Indications and uses
temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion stuffy nose sore throat minor aches and pains headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more ...
Dosage and administration
this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) do not give more than 5 doses in any 24-hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. keep dosing cup ...
temporarily relieves these common cold and flu symptoms:
cough due to minor throat and bronchial irritation
the intensity of coughing
the impulse to cough to help your child get to sleep
nasal congestion
stuffy nose
sore throat
minor aches and pains
headache
temporarily reduces fever
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 warnings: This product contains acetaminophen. Severe liver damage may occur if you child takes:
more than 5 doses in 24 hours,which is the maximum daily amount
with other drugs containing acetaminophen
Allergy alert: 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: 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.
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if your child has
OTC - ASK DOCTOR SECTION
liver disease
heart disease
high blood pressure
diabetes
thyroid disease
cough that occurs with too much phlegm (mucus)
a breathing problem such as chronic bronchitis
persistent or chronic cough such as occurs with asthma
Ask a doctor or pharmacist before use if your child is
SPL UNCLASSIFIED SECTION
taking the blood thinning drug warfain
When using this product,
OTC - WHEN USING SECTION
do not use more than directed (see Overdose warning).
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 5 days
redness or swelling is present
new symptoms occur
fever get worse or lasts more than 3 days
cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
DOSAGE & ADMINISTRATION SECTION
this product does not contain directions or complete warnings for adult use
do not give more than directed (see Overdose warning)
do not give more than 5 doses in any 24-hour period
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 days unless directed by a doctor
use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
keep dosing cup with product
dose as follows or as directed by a doctor
mL = milliliter
children 6 to under 12 years of age: 10 mL in dosing cup provided
children under 6 years of age: do not use
Other information
SPL UNCLASSIFIED SECTION
each 10 mL contains: sodium 6 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.