REGULAR STRENGTH LAXATIVE- sennosides 15 mg tablet

Regular Strength Laxative by

Drug Labeling and Warnings

Regular Strength Laxative by is a Otc medication manufactured, distributed, or labeled by WinCo Foods LLC, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Sennosides USP, 15 mg

PURPOSE

Purpose

Stimulant Laxative

INDICATIONS & USAGE

Uses
relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to12 hours

WARNINGS

Warnings

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor before use if you have

• noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you

• are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When using this product

• do not use for a period longer than 1 week

Stop use and ask a doctor if

• rectal bleeding or failure to have a bowel movement occur after use of a laxative.

These may 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.

DOSAGE & ADMINISTRATION

Directions

Swallow tablet(s) with a glass of water
Swallow tablet(s) whole, do not crush, break, or chew.

• adults and children 12 years of age and older: take 2 tablets once or twice daily
• children 6 to under 12 years of age: take 1 tablet once or twice daily
• children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information
each tablet contains: calcium 50 mg, sodium 2 mg (VERY LOW SODIUM)
store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

Inactive ingredient acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sugar, talc, titanium dioxide

QUESTIONS

Questions? Call 1-800-824-1706
Monday – Friday 9am – 4pm MST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH LAXATIVE 
sennosides 15 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-384
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	15 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RAW SUGAR (UNII: 8M707QY5GH)
ACACIA (UNII: 5C5403N26O)
KAOLIN (UNII: 24H4NWX5CO)
TALC (UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL079
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-384-24	1 in 1 CARTON	01/14/2022
1		24 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	01/14/2022

Labeler - WinCo Foods LLC (056098817)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(67091-384)