Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections
Indications and uses
• temporarily relieves these common cold and flu symptoms: • cough • nasal congestion • minor aches and pains • sinus congestion and pressure • sore throat • headache • runny nose • sneezing • temporarily reduces fever • controls cough to help you get to sleep
Dosage and administration
• do not take more than directed (see Overdose warning) • do not take more than 5 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours • children under 12 years of age: do not use
Storage and handling
• each 20 mL contains: sodium 7 mg • store at 20-25 ° C (68-77 ° F) • dosing cup provided • do not refrigerate
temporarily relieves these common cold and flu symptoms:
cough
nasal congestion
minor aches and pains
sinus congestion and pressure
sore throat
headache
runny nose
sneezing
temporarily reduces fever
controls cough to help you get to sleep
Warnings
WARNINGS SECTION
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 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.
with any other product containing diphenhydramine, even one used on skin
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.
if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
liver disease
heart disease
diabetes
high blood pressure
thyroid disease
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
When using this product
OTC - WHEN USING SECTION
do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
OTC - STOP USE SECTION
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.
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
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.
Directions
DOSAGE & ADMINISTRATION SECTION
do not take more than directed (see Overdose warning)
do not take more than 5 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
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