FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Packet)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
- •temporarily relieves these symptoms due to a cold:
- •minor aches and pains
- •minor sore throat pain
- •nasal and sinus congestion
- •cough due to minor throat and bronchial irritation
- •temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •more than 4,000 mg of acetaminophen in 24 hours
- •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
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
- •in a child under 12 years of age
- •if you have ever had an allergic reaction to this product or any of its ingredients
- •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.
Ask A Doctor Before Use If You Have
- •liver disease
- •heart disease
- •high blood pressure
- •thyroid disease
- •trouble urinating due to an enlarged prostate gland
- •cough that occurs with too much phlegm (mucus)
- •cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- •a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not exceed recommended dosage
Stop Use And Ask A Doctor If
- •nervousness, dizziness, or sleeplessness occurs
- •fever gets worse or lasts more than 3 days
- •redness or swelling is present
- •new symptoms occur
- •pain, cough or nasal congestion gets worse or lasts more than 7 days
- •cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- •do not use more than directed (see overdose warning)
- •take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
adults and children 12 years of age and over
children under 12 years of age
do not use
- •dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- •if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
- •each packet contains: potassium 10 mg and sodium 25 mg
- •phenylketonurics: contains phenylalanine 22 mg per packet
- •store at 20-25°C (68-77°F). Protect product from heat and moisture.
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate
Package/Label Principal Display Panel
Multi-Symptom Flu & Severe Cold
Pain Reliever/Fever Reducer
Green Tea & Honey Lemon Flavors
Nasal Congestion, Cough, Body Ache, Sore Throat Pain, Headache, Fever
COMPARE TO THERAFLU®
MULTI-SYMPTOM SEVERE COLD
100% Money Back Guarantee
* Please review the disclaimer below.