The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Softgel)
Acetaminophen 325 mg Dextromethoprhan HBr 10 mgPhenlyephrine HCl 5 mg
Pain reliever/fever reducerCough suppressantNasal decongestant
- Temporarily relieves common cold and flu symptomsminor aches and pains
- Sore throat
- Nasal congestion
- Cough due to minor throat and bronchial irritation
- 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 productAllergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:skin reddeningblistersrashIf 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
- 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
- Thyroid disease
- High blood pressure
- Trouble urinating due to an enlarged prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough that occurs with too much phlegm (mucus)
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
- Pain, cough, or nasal congestion gets worse or lasts more than 7 daysnervousness, dizziness, or sleeplessness occur
- Fever gets worse or lasts more than 3 days
- Redness or swelling is presentnew symptoms occur
- Cough comes back or occurs with rash or headache that lastsThese could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: Taking more than the recommended dose can 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.
- Do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours
- Adults and children 12 years and over: take 2 softgels with water every 4 hours
- Swallow whole; do not crush, chew, or dissolve
- Children under 12 years: do not use
- When using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Store between 15º-30ºC (59º-86ºF)
- Avoid excessive heat
FD&C red #40, FD&C yellow#6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
LEADER Cold & Flu Relief
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