CVS NIGHTTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution
CVS Pharmacy
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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CVS Nighttime Severe Cold & Flu Relief
Active Ingredients (in each Single-Use Vial, 30mL)
Acetaminophen USP, 650mg
Dextromethorphan HBr, USP, 20mg
Doxylamine succinate, USP, 12.5mg
Phenylephrine HCl, USP, 10mg
Uses
Temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ cough to help you sleep ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ runny nose & sneezing ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 vials 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
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 ■ to make a child sleep
Ask a doctor before use if you have
■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease
■ diabetes ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ trouble urinating due to enlarged prostate gland
When using this product
■ do not use more than directed ■ 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
■ you get nervous, dizzy or sleepless ■ 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.
Directions
■ do not take more than directed
■ empty each Single-Use Vial of all liquid when dosing.
■ use the chart below to confirm the dose
| Age (Years) | Dose |
| Children under 4 years old | Do not use |
| Children 4 to under 12 years old | Ask a doctor |
| Adults and children 12 years and over |
1 Single Use Vial (30mL) every 4 hours while symptoms last Do not exceed 4 Single Use Vials in 24 hours |
Other information
■ each single-use vial (30 mL) contains 31mg of sodium
■ Store at 20-25oC (68-77oF)
■ Tamper Evident: do not use if the clear sealing label is broken or missing. Do not use if any vial is open or broken.
| CVS NIGHTTIME SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution |
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| Labeler - CVS Pharmacy (062312574) |