Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Label structure8 sections
Indications and 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
Dosage and administration
■ 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
Active Ingredients (in each Single-Use Vial, 30mL)
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen USP, 650mg
Dextromethorphan HBr, USP, 20mg
Doxylamine succinate, USP, 12.5mg
Phenylephrine HCl, USP, 10mg
Purposes
OTC - PURPOSE SECTION
Pain Reliever/ Fever reducer
Cough suppressant
Antihistamine
Nasal Decongestant
Uses
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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
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 ■ to make a child sleep
■ 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
OTC - WHEN USING SECTION
■ 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
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
Keep out of reach of children
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
■ 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
OTHER SAFETY 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.
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