Label: SENNOSIDES AND DOCUSATE SODIUM tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63739-432-01, 63739-432-02, 63739-432-04, 63739-432-10 - Packager: McKesson Packaging Services a business unit of McKesson Corporation
- This is a repackaged label.
- Source NDC Code(s): 49483-081
- 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.
Drug Label Information
Updated July 28, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
Do Not Use
- this product if you are presently 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
- nausea
- vomiting
- a sudden change in bowel movements that persists 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 could be signs of 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 right away
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Directions
- Take preferably at bedtime or as directed by a doctor
- If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.
Age Starting Dose Maximum Dose 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 tablets twice a day Children under 2 years ask a doctor ask a doctor - Inactive ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
SENNOSIDES AND DOCUSATE SODIUM
sennosides and docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-432(NDC:49483-081) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL081 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63739-432-10 10 in 1 BOX, UNIT-DOSE 11/10/2007 07/31/2021 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63739-432-01 25 in 1 BOX, UNIT-DOSE 11/10/2007 07/31/2021 2 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63739-432-04 25 in 1 BOX 11/10/2007 05/31/2013 3 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:63739-432-02 30 in 1 BOX 07/28/2021 4 10 in 1 BLISTER PACK; 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 10/11/2007 Labeler - McKesson Packaging Services a business unit of McKesson Corporation (140529962) Establishment Name Address ID/FEI Business Operations Legacy Pharmaceutical Packaging, LLC 143213275 repack(63739-432) , relabel(63739-432)