MAXIMUM STRENGTH LAXATIVE- sennosides tablet

MAXIMUM STRENGTH LAXATIVE by

Drug Labeling and Warnings

MAXIMUM STRENGTH LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Kroger Company, TIME CAP LABORATORIES, INC, TIME CAP LABS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Sennosides USP, 25 mg

PURPOSE

Purpose

Stimulant laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

DO NOT USE

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

ASK 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 DOCTOR/PHARMACIST

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

When using this product do not use for a period longer than 1 week

WHEN USING

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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

• 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:

  2 tablets once or twice daily

• children 6 to under 12 years of age:

  1 tablet once or twice daily

• children under 6 years of age:

  ask a doctor

OTHER SAFETY INFORMATION

Other information

• each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
• store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH LAXATIVE 
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-195
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	25 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ACACIA (UNII: 5C5403N26O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
SUCROSE (UNII: C151H8M554)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
STEARIC ACID (UNII: 4ELV7Z65AP)
IRON OXIDES (UNII: 1K09F3G675)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL083
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-195-24	24 in 1 CARTON; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	06/01/2020

Labeler - Kroger Company (006999528)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS		037052099	manufacture(41226-195)