STOOL SOFTENER AND STIMULANT LAXATIVE- docusate sodium, sennosides tablet

Stool Softener and Stimulant Laxative by

Drug Labeling and Warnings

Stool Softener and Stimulant Laxative by is a Otc medication manufactured, distributed, or labeled by H-E-B, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purposes

Stool Softener

Stimulant laxative

USES

Uses

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

WARNINGS

Warnings

Do not use

• laxative products for longer than 1 week unless told to do so by a doctor
• if you are presently taking mineral oil unless told to do so 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 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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
• Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

QUESTIONS

Questions or comments call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STOOL SOFTENER AND STIMULANT LAXATIVE 
docusate sodium, sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-549
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-549-29	240 in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/04/2022

Labeler - H-E-B (007924756)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(37808-549)