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Drug Facts
Senna Leaf And Docusate Sodium
FDA Label NDC 65437-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Himprit Pharmachem Pvt Ltd for the product Senna Leaf And Docusate Sodium (NDC 65437-035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, directions, inactive ingredients, principal display panel - shipping label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Docusate sodium 50 mg | Stool softener |
| Sennosides 8.6 mg | Laxative |
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
Directions
- 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 |
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, sodium benzoate, stearic acid, tartaric acid, titanium dioxide
Principal Display Panel - Shipping Label
SENNA 8.6mg & DOCUSATE SODIUM 50mg
Orange Tablets
Each Tablet Contains:
CALCIUM SENNOSIDES 8.6mg
DOCUSATE SODIUM 50mg
| Lot No: | Quantity: |
| Mfg Date: | Jar No: |
| Exp Date: | NDC NO: 65437-035-50 |
WARNING:
KEEP OUT OF THE REACH OF CHILDREN
STORE AT CONTROLLED ROOM TEMPERATURE OF 59 - 77 F (15 - 25 C)
PROTECT FROM LIGHT,MOISURE AND FREEZING.
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D. & C. ACT AND REGULATIONS THEREUNDER.
MANUFACTURED BY:
MANUFACTURED CODE NO Guj/Drugs/G/1362
LABELLER CODE # 14803
MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT.LTD.
"LAKULISH" R.V.DESAI ROAD
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA 390 001
Principal Display Panel (Shipping Label)
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