Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure17 sections
Indications and uses
temporarily relieves minor aches and pains sore throat headache nasal and sinus congestion temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
Dosage and administration
take only as recommended (see Overdose warning) use dose cup or tablespoon (TBSP) do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose Children under Do not use 12 years of age Adults & children 12 2 tablespoonful years and over 30 mL every 4 hours
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
Warnings
WARNINGS SECTION
Liver warning This product contains acetaminophen.
Severe liver damage may occur if you take:
more than 6 doses in 24 hours, which is the maxium daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin. 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.
if you are now 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.f you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
for children under 12 years of age
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
liver disease
heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, 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
When using this product
OTC - WHEN USING SECTION
do not use more than directed
Stop use and ask a doctor if
OTC - STOP USE SECTION
nervousness, dizziness or sleeplessness occur
redness or swelling is present
symptoms do not get better within 7 days or are accompanied by a fever
fever gets worse or lasts more than 3 days
new symptoms occur
cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache. These could be signs of a serious condition
If pregnant or breast feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a 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
OVERDOSAGE 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 for adults as well as for children even if you do not noitce any signs or symptoms.
Directions
DOSAGE & ADMINISTRATION SECTION
take only as recommended (see Overdose warning)
use dose cup or tablespoon (TBSP)
do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
Age Dose Children under Do not use 12 years of age
Adults & children 12 2 tablespoonful years and over 30 mL every 4 hours
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Failure to follow these warnings could result in serious consequences
* This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Theraflu® Cold & Chest Congestion.
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINIA, OHIO 44256
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.