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 this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
to make a child sleep (Nighttime only)
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
liver disease
cough that occurs with too much phlegm (mucus)
trouble urinating due to enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis
glaucoma (Nighttime only)
diabetes (Daytime only)
heart disease (Daytime only)
thyroid disease (Daytime only)
high blood pressure (Daytime only)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Nighttime only)
When using this product
do not exceed recommended dosage
In addition, when using Nighttime:
excitability may occur, especially in children
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur (Daytime only)
pain, cough, and (for Daytime only) nasal congestion 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,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
Do not use
to make a child sleep (Nighttime only)
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
liver disease
cough that occurs with too much phlegm (mucus)
trouble urinating due to enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis
glaucoma (Nighttime only)
diabetes (Daytime only)
heart disease (Daytime only)
thyroid disease (Daytime only)
high blood pressure (Daytime only)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Nighttime only)
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur (Daytime only)
pain, cough, and (for Daytime only) nasal congestion 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
do not take more than directed (see overdose warning)
do not take more than 4 doses in 24 hours
swallow whole: do not crush, chew, or dissolve
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours
Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours
children under 12 years: do not use
do not exceed 4 doses per 24 hours
take only as directed – see overdose warning
Adults and children 12 years and over: 2 softgels with water every 4 hours
children under 12 years: ask a doctor
Children under 4 years: do not use
NightTime Cold and Flu
do not exceed 4 doses per 24 hours
take only as directed – see overdose warning
Adults and children 12 years and over: 2 softgels with water every 4 hours
children under 12 years: ask a doctor
Children under 4 years: do not use
Daytime Nighttime Cold/flu | American Health Packaging
2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.