LAXATIVE- sennosides, 25 mg tablet, film coated

Laxative by

Drug Labeling and Warnings

Laxative by is a Otc medication manufactured, distributed, or labeled by Granulation Technology, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)
Sennosides, 25 mg

PURPOSE

Purpose

Stimulant Laxative

Uses

• Relieves occasional constipation (irregularity)
• Generally produces a bowel movement in 6-12 hours

Warnings

DO NOT USE

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

ASK DOCTOR

Ask a doctor before use if you havenoticed 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 aretaking 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 productdo not use for a period longer than 1 week.

STOP USE

Stop use and ask a doctor ifrectal 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 reach of children.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

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

• Age: Dosage
• adults and children 12 years of age and over: 2 tablets once or twice daily
• children 6 to under 12 years: 1 tablet once a day or twice daily
• children under 6 years: Ask a doctor

Other information

• Each tablet contains:Calcium 40 mg, Magnesium 5 mg
• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• Use by expiration date on package

Inactive ingredients

croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, yellow iron oxide, FD&C blue 1 lake

QUESTIONS

Questions or comments?

call 1-973-276-0740

Principal Display Panel

NDC: 63561-0186-9

Laxative Tablets Label

SENNOSIDES, 25 mg / STIMULANT LAXATIVE

Compare to ex.lax ® Maximum Strength Active Ingredient

90 Film-Coated Tablets

INGREDIENTS AND APPEARANCE

LAXATIVE 
sennosides, 25 mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63561-0186
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G186
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63561-0186-9	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/17/2024

Labeler - Granulation Technology, Inc. (847132193)

Registrant - Granulation Technology, Inc. (847132193)

Establishment
Name	Address	ID/FEI	Business Operations
Granulation Technology, Inc.		847132193	manufacture(63561-0186)