680 Laxative Senna S with Stool softener

Natural Vegetable Laxative with Stool Softener by

Drug Labeling and Warnings

Natural Vegetable Laxative with Stool Softener by is a Otc medication manufactured, distributed, or labeled by Medline Industries, P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURAL VEGETABLE LAXATIVE WITH STOOL SOFTENER- docusate sodium and sennosides tablet 
Medline Industries

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.

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680 Laxative Senna S with Stool softener

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

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

Warnings

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
  • nausea
  • vomiting
  • 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.

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.

Directions

  • take preferably at bedtime or as directed by a doctor
  age  starting dosage  maximum dosage
 adults and children 12 years of age or older2 tablets
once a day
4 tablets
twice a day
 children 6 to under 12 years1 tablet
once a day
2 tablets
twice a day
 children 2 to under 6 years1/2 tablet
once a day
1 tablet
twice a day
 children under 2 years ask a doctor ask a doctor

Other information

  • each tablet contains: c alcium 20 mg
  • each tablet contains: sodium 6 mg  VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9AM-5PM CST

Principal Display Panel

**Compare to the active ingredients in Senokot-S® 

NATURAL VEGETABLE LAXATIVE

WITH STOOL SOFTENER

Gentle, Overnight Relief of Constipation

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

TABLETS

Distributed by: Medline Industries, Inc.

One Medline Place, Mundelein, IL  60060

**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Label

Docusate sodium 50 mg; Sennosides 8.6 mg
NATURAL VEGETABLE LAXATIVE WITH STOOL SOFTENER 
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-680
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL081;SS1;S35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-680-6260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201312/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/30/201312/31/2019
Labeler - Medline Industries (025460908)
Establishment
NameAddressID/FEIBusiness Operations
PLD Acquisitions LLC D/B/A Avema Pharma Solutions804087794pack(53329-680) , manufacture(53329-680)

Revised: 1/2020
 
Medline Industries