OTC Medication Information: Stool Softener with Laxative

STOOL SOFTENER WITH LAXATIVE- docusate sodium and sennosides tablet
AmerisourceBergen (Good Neighbor Pharmacy) 46122

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.

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 hours

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are now taking mineral oil, 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 a period of 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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and older take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 ask a doctor

Other information

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

Inactive ingredients

carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Colace® 2-IN-1†

Stool Softener and

Stimulant Laxative

Docusate sodium 50 mg

Sennosides 8.6 mg

A Gentle, Predictable Laxative

tablets

This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

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

Distributed by AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087

www.mygnp.com

Product Label

Docusate Sodium 50 mg, Sennosides 8.6 mg
(click image for full-size original)

GOOD NEIGHBOR PHARMACY Stool Softener and Stimulant Laxative

STOOL SOFTENER WITH LAXATIVE
docusate sodium and sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-567
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C RED NO. 40
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM BENZOATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
ALUMINUM OXIDE
FD&C BLUE NO. 2
Product Characteristics
Color red Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TCL097;PSD21;S44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46122-567-78 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 12/31/2018 12/27/2024
Labeler — AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 09/2022 AmerisourceBergen (Good Neighbor Pharmacy) 46122

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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