Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 sections
Indications and uses
temporarily relieves these common cold/flu symptoms: • minor aches and pains • headache • muscular aches • sore throat • fever • runny nose and sneezing • itchy nose or throat • coughs • cough due to minor throat and bronchial irritation • itchy, watery eyes due to hay fever or other upper respiratory allergies
Dosage and administration
• use dosage cup or tablespoon (TBSP) • take only as recommended (see overdose warning) • do not exceed 4 doses per 24 hours age dose adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours children 4 years to under 12 years.......................do not use unless directed by a doctor children under 4 years.........
temporarily relieves these common cold/flu symptoms: • minor aches and pains • headache • muscular aches • sore throat • fever • runny nose and sneezing • itchy nose or throat • coughs • cough due to minor throat and bronchial irritation • itchy, watery eyes due to hay fever or other upper respiratory allergies
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4 doses (8 tablespoonfuls or 120 mL) in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks everyday while using this product Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, rash, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 12 years of age unless directed by a doctor.
Do Not Use
OTC - DO NOT USE SECTION
• to make a child sleepy • if you are on a sodium-restricted diet • 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 two 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. • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
• liver disease • glaucoma • breathing problems • chronic bronchitis • trouble urinating due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking
OTC - ASK DOCTOR/PHARMACIST SECTION
• sedatives or tranquilizers • the blood thinning drug warfarin
When using this product
OTC - WHEN USING SECTION
• do not use more than directed (see overdose warning) • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
OTC - STOP USE SECTION
• redness or swelling is present • new symptoms occur • you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days • pain or cough gets worse or lasts more than 7 days • cough comes back or occurs with 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 a health professional before use.
Keep this and all drugs out of the reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Overdose Warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. 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
• use dosage cup or tablespoon (TBSP) • take only as recommended (see overdose warning) • do not exceed 4 doses per 24 hours
agedose adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours children 4 years to under 12 years.......................do not use unless directed by a doctor children under 4 years..........................................do not use
• When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
Other Information
SPL UNCLASSIFIED SECTION
• store at controlled room temperature • sodium content per tablespoon: 18 mg
Inactive Ingredients
INACTIVE INGREDIENT SECTION
alcohol, blue 1, citric acid, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, red 40, saccharin sodium, sodium citrate
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