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 Caplet) - Day Time Severe Cold
Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg
Active Ingredients (In Each Caplet) – Night Time Cold & Flu
Acetaminophen 325 mgDiphenhydramine HCl 25 mgPhenylephrine HCl 5 mg
Purposes - Day Time Severe Cold
Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant
Purposes - Night Time Cold & Flu
Pain reliever/fever reducerAntihistamineNasal decongestant
- •temporarily relieves these common cold and flu symptoms: •nasal congestion •cough (DAY TIME Severe Cold only) •minor aches and pains •headache •sore throat •runny nose and sneezing (NIGHT TIME Cold & Flu only) •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only) •temporarily reduces fever
- Liver warning: These products contain 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 these productsAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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. •with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold & Flu only) •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 these products. •if you have ever had an allergic reaction to these products or any of their ingredients
Ask A Doctor Before Use If You Have
- •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •glaucoma (NIGHT TIME Cold & Flu only) •a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME Cold & Flu only) •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME Severe Cold only) •cough that occurs with too much phlegm (mucus) (DAY TIME Severe Cold only)
Ask A Doctor Or Pharmacist Before Use If You Are
- •taking the blood thinning drug warfarin •taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)
When Using These Products
- •do not use more than directed •excitability may occur, especially in children (NIGHT TIME Cold & Flu only) •marked drowsiness may occur (NIGHT TIME Cold & Flu only) •alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only) •avoid alcoholic drinks (NIGHT TIME Cold & Flu only) •be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)
Stop Use And Ask A Doctor If
- •nervousness, dizziness, or sleeplessness occur •pain, nasal congestion 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. (DAY TIME Severe Cold only)
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). 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 10 caplets in any 24-hour period •adults and children 12 years of age and older: take 2 caplets every 4 hours •children under 12 years of age: do not use
- •each caplet contains: sodium 4 mg (DAY TIME Severe Cold only) •store at 20-25°C (68-77°F)
Inactive Ingredients - Day Time Severe Cold
Croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Inactive Ingredients – Night Time Cold & Flu
Crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
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