Complete SPL Sections
Drug Facts
SPL UNCLASSIFIED SECTION
OTC - ACTIVE INGREDIENT SECTION
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
OTC - PURPOSE SECTION
OTC - PURPOSE SECTION
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
INDICATIONS & USAGE SECTION
INDICATIONS & USAGE SECTION
Uses temporarily relieves common cold/flu symptoms: -cough due to minor throat and bronchial irritation -sore throat -headache -minor aches and pains -fever -runny nose and sneezing
WARNINGS SECTION
WARNINGS SECTION
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take -more than 4 doses in 24 hours, which is the maximum daily amount for this product -with other drugs containing acetaminophen -3 or more alcoholic drinks every day while using this product 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.
OTC - DO NOT USE SECTION
OTC - DO NOT USE SECTION
Do not use -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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR SECTION
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have -liver disease -glaucoma -cough that occurs with too much phlegm (mucus) -a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema -trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are -taking sedatives or tranquilizers -taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
OTC - WHEN USING SECTION
When using this product -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
OTC - STOP USE SECTION
OTC - STOP USE SECTION
Stop use and ask a doctor if -pain 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 rash or headache that lasts. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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.
DOSAGE & ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION SECTION
Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over-30 mL every 6 hrs children 4 to under 12 yrs-ask a doctor children under 4 yrs-do not use
OTHER SAFETY INFORMATION
OTHER SAFETY INFORMATION
Other information each 30 mL contains: sodium 52 mg store at no greater than 25°C and do not refrigerate
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
OTC - QUESTIONS SECTION
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008