Label: SENNA-DOC- senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated
71309-113-24, view more71309-113-25, 71309-113-50
- Packager: 3014704014
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 2, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Do not use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that lasts over 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.
take preferably at bedtime or as directed by a doctor
- adults and children 12 years of age or older - starting dosage: 2 tablets once a day, maximum dosage: 4 tablets twice a day
- children 6 to under 12 years - starting dosage: 1 tablet once a day, maximum dosage: 2 tablets twice a day
- children 2 to under 6 years - starting dosage: 1/2 tablet once a day, maximum dosage: 1 tablet twice a day
- children under 2 years - starting dosage: ask a doctor, maximum dosage: ask a doctor
- Other information
- Inactive ingredients
Questions or comments?
Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code S35 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71309-113-25 25 in 1 BOX 04/08/2016 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:71309-113-50 50 in 1 BOX 04/08/2016 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:71309-113-02 2 in 1 POUCH 04/08/2016 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:71309-113-10 1000 in 1 BOTTLE 04/08/2016 4 NDC:71309-113-05 500 in 1 BOTTLE 4 NDC:71309-113-24 24 in 1 BOTTLE 4 1 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/07/2016 Labeler - 3014704014 (080566287)