Drugplain

Senna Laxative 8.6 mg/1

Senna · TABLET, FILM COATED · PD-Rx Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Senna Laxative is an over-the-counter oral medication used to relieve constipation by stimulating bowel movements. It comes as a film-coated tablet containing 8.6 mg of senna per dose.

Key Facts

Brand Name
Senna Laxative
Generic Name
Senna
NDC Code (Product)
43063-838
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Strength
8.6 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
01/24/2007

Recall History

1 Recall on Record
Class I01/17/2018

Magno Humphries Laboratories, Inc

Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue643 reports
off label use636 reports
pain611 reports
constipation599 reports
pyrexia563 reports
headache543 reports
asthma535 reports
dyspnoea535 reports
drug ineffective485 reports
febrile neutropenia478 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours

Dosage & Administration

Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and over 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

Warnings

Warnings Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a periodof 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Senna Laxative used for?

Senna Laxative is an over-the-counter oral medication used to relieve constipation by stimulating bowel movements. It comes as a film-coated tablet containing 8.6 mg of senna per dose.

Is Senna Laxative a controlled substance?

Senna Laxative is not classified as a controlled substance by the DEA.

What is the generic name for Senna Laxative?

The generic name for Senna Laxative is Senna. There are 10 other brand versions of Senna.

What is the NDC code for Senna Laxative 8.6 mg/1?

The NDC (National Drug Code) for Senna Laxative 8.6 mg/1 is 43063-838, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

43063-838

Package NDC

43063-838-10

Other Senna Laxative Dosages

Other Senna Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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