Senna-lax

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Senna-lax Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Do not use

laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
noticed a sudden change in bowel habits that continues over a period of 2 weeks

stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Do not use

laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
noticed a sudden change in bowel habits that continues over a period of 2 weeks

stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
noticed a sudden change in bowel habits that continues over a period of 2 weeks

stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

relieves: occasional constipation (irregularity)

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Senna-lax Manufacturers

Guardian Drug Company

Senna-lax | Guardian Drug Company

take preferably at bedtime expect results in 6-12 hours adults and children 12 years and over do not exceed 8 tablets in 24 hours children 6 to under 12 years do not exceed 4 tablets in 24 hours children 2 to under 6 years do not exceed 2 tablets in 24 hours do not exceed the maximum dosage of this product adults and children 12 years and over 2 tablets once daily (maximum: 4 tablets twice a day) children 6 to under 12 years 1 tablet once daily (maximum: 2 tablets twice a day) children 2 to under 6 years 1/2 tablet once daily (maximum: 1 tablet twice a day) childrem under 2 years ask a doctor

No Recall
Stephen L. Lafrance Pharmacy, Inc.

Senna-lax | L&r Distributors, Inc.

take preferably at bedtime or as directed by a doctor
age

starting dosage

maximum dosage

adults and children 12 years of age or older

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

No Recall
Major Pharmaceuticals

Senna-lax | Major Pharmaceuticals

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years of age
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years of age
1/2 tablet once a day
1 tablet twice a day
children under 2 years of age
ask a doctor
ask a doctor

No Recall
Cardinal Health

Senna-lax | White Manufacturing Dba Micro-west

DIRECTIONS: Take 2 pump sprays 3 times daily. Hold under tongue for 30 seconds before swallowing. More frequent dosages may be used according to symptomatic needs. For ages 2 to adult

No Recall
Mckesson Contract Packaging

Senna-lax | Mckesson Contract Packaging

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years of age
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years of age
1/2 tablet once a day
1 tablet twice a day
children under 2 years of age
ask a doctor
ask a doctor

No Recall
Qualitest Pharmaceutical, Inc.

Senna-lax | Oceanside Pharmaceuticals

Because of the risk of potentially fatal, acute fulminant liver failure, tolcapone tablets should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION sections).

BECAUSE OF THE RISK OF LIVER INJURY AND BECAUSE TOLCAPONE TABLETS WHEN IT IS EFFECTIVE PROVIDES AN OBSERVABLE SYMPTOMATIC BENEFIT, THE PATIENT WHO FAILS TO SHOW SUBSTANTIAL CLINICAL BENEFIT WITHIN 3 WEEKS OF INITIATION OF TREATMENT, SHOULD BE WITHDRAWN FROM TOLCAPONE TABLETS.

Tolcapone tablets therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

Patients who develop evidence of hepatocellular injury while on tolcapone tablets and are withdrawn from the drug for any reason may be at increased risk for liver injury if tolcapone tablets is reintroduced. These patients should not ordinarily be considered for retreatment with tolcapone tablets.

Only prescribe tolcapone tablets for patients taking concomitant carbidopa levodopa therapy. The initial dose of tolcapone tablets is always 100 mg three times per day. The recommended daily dose of tolcapone tablets is also 100 mg tid. In clinical trials, elevations in ALT occurred more frequently at the dose of 200 mg tid. While it is unknown whether the risk of acute fulminant liver failure is increased at the 200-mg dose, it would be prudent to use 200 mg only if the anticipated incremental clinical benefit is justified (see BOXED WARNING, WARNINGS, PRECAUTIONS: Laboratory Tests). If a patient fails to show the expected incremental benefit on the 200-mg dose after a total of 3 weeks of treatment (regardless of dose), tolcapone tablets should be discontinued.

In clinical trials, the first dose of the day of tolcapone tablets was always taken together with the first dose of the day of levodopa/carbidopa, and the subsequent doses of tolcapone tablets were given approximately 6 and 12 hours later.

In clinical trials, the majority of patients required a decrease in their daily levodopa dose if their daily dose of levodopa was >600 mg or if patients had moderate or severe dyskinesias before beginning treatment.

To optimize an individual patient's response, reductions in daily levodopa dose may be necessary. In clinical trials, the average reduction in daily levodopa dose was about 30% in those patients requiring a levodopa dose reduction. (Greater than 70% of patients with levodopa doses above 600 mg daily required such a reduction.)

Tolcapone tablets can be combined with both the immediate and sustained release formulations of levodopa/carbidopa.

Tolcapone tablets may be taken with or without food (see CLINICAL PHARMACOLOGY).
Patients With Impaired Hepatic Function
Tolcapone tablets therapy should not be initiated in any patient with liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. (See BOXED WARNING, WARNINGS, and CLINICAL PHARMACOLOGY).
Patients With Impaired Renal Function
No dose adjustment of tolcapone tablets is recommended for patients with mild to moderate renal impairment. However, patients with severe renal impairment should be treated with caution. The safety of tolcapone has not been examined in subjects who had creatinine clearance less than 25 mL/min (see CLINICAL PHARMACOLOGY).
Withdrawing Patients From Tolcapone tablets
As with any dopaminergic drug, withdrawal or abrupt reduction in the Tolcapone tablets dose may lead to emergence of signs and symptoms of Parkinson's disease or Hyperpyrexia and Confusion, a syndrome complex resembling the neuroleptic malignant syndrome (see PRECAUTIONS: Events Reported With Dopaminergic Therapy). If a decision is made to discontinue treatment with Tolcapone tablets, then it is recommended to closely monitor the patient and adjust other dopaminergic treatments as needed. This syndrome should be considered in the differential diagnosis for any patient who develops a high fever or severe rigidity. Tapering tolcapone tablets has not been systematically evaluated. As the duration of COMT inhibition with tolcapone tablets is generally 5 to 6 hours on average, decreasing the frequency of dosage to twice or once a day may not in itself prevent withdrawal effects.

No Recall
Bryant Ranch Prepack

Senna-lax | Bryant Ranch Prepack

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older
2 tablets once a day
4 tablets twice a day
children 6 to under 12 years of age
1 tablet once a day
2 tablets twice a day
children 2 to under 6 years of age
1/2 tablet once a day
1 tablet twice a day
children under 2 years of age
ask a doctor
ask a doctor

No Recall
Preferred Pharmaceuticals, Inc.

Senna-lax | Preferred Pharmaceuticals, Inc.

• Take preferably at bedtime or as directed by doctor • If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
Age Starting dosage Maximum dosage Adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years consult a doctor

No Recall
Directrx

Senna-lax | Directrx

• Take preferably at bedtime or as directed by doctor • If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
Age Starting dosage Maximum dosage Adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years consult a doctor

No Recall