This product contains acetaminophen. Severe liver damage may occur if you take:
more than 12 gelcaps in 24 hours, which is the maximum daily amount
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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
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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
diabetes
heart disease
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma
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
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
When using this product
do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
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 (overdose) may 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 as well as for children even if you do not notice any signs or symptoms.
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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
diabetes
heart disease
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma
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
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
cough comes back or occurs with rash or headache that lasts.
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 gelcaps every 4 hours
do not take more than 12 gelcaps in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once Daily***
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily**
* For adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered.
** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
*** Controlled studies did not extend beyond 12 months
2.2 Administration Instructions
Directions for method of administration for each dosage form are presented in Table 2.
Formulation
Route
Instructions*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
* Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Adults: The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly.
Pediatric patients over 5 years of age: The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
•
this product does not contain directions or complete warnings for adult use
•
do not give more than directed (see overdose warning)
•
shake well before using
•
mL = milliliter; tsp = teaspoonful
•
find right dose on chart. If possible, use weight to dose; otherwise, use age.
•
remove the child protective cap and squeeze your child’s dose into the dosing cup
•
repeat dose every 4 hours while symptoms last
•
do not give more than 5 times in 24 hours
Weight (lb)
Age (yr)
Dose (mL or tsp)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL (1 tsp)
36-47
4-5 years
7.5 mL (1 1/2 tsp)
48-59
6-8 years
10 mL (2 tsp)
60-71
9-10 years
12.5 mL (2 1/2 tsp)
72-95
11 years
15 mL (3 tsp)
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
do not take more than directed (see overdose warning)
adults and children 12 years and over:
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor
do not take more than directed (see overdose warning)
adults and children 12 years and over:
take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor