ProductCVS Health Daytime Severe Cold and Flu Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 sections
Indications and uses
temporarily relieves common cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial pa...
Dosage and administration
Directions ■ do not take more than directed ■ empty each Single-Use Vial of all liquid when dosing. ■ use the chart below to confirm 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 2 Single Use Vials (15 mL) Every 4 hours while symptoms last Do not exceed 8 Single Use Vials in 24 hours
Active Ingredients (in each Single-Use Vial, 15mL)
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen USP, 325mg
Dextromethorphan HBr, USP, 10mg
Guaifenesin, USP 200mg
Phenylephrine HCl, USP, 5mg
Purposes
OTC - PURPOSE SECTION
Pain Reliever/ Fever reducer
Cough suppressant
Expectorant
Nasal Decongestant
Uses
INDICATIONS & USAGE SECTION
temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 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
OTC - DO NOT USE SECTION
■ 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
OTC - ASK DOCTOR SECTION
■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking the blood thinning drug warfarin.
When using this product
OTC - WHEN USING SECTION
do not use more than directed
Stop use and ask a doctor if
OTC - STOP USE SECTION
■ 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.
If pregnant or breast-feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions:
DOSAGE & ADMINISTRATION SECTION
Directions
■ do not take more than directed
■ empty each Single-Use Vial of all liquid when dosing.
■ use the chart below to confirm 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
2 Single Use Vials (15 mL) Every 4 hours while symptoms last
Do not exceed 8 Single Use Vials in 24 hours
Other information:
OTHER SAFETY INFORMATION
■ each single-use vial (15 mL) contains 16mg 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.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.