SENNA-LAX- sennosides tablet, film coated

Senna-Lax by

Drug Labeling and Warnings

Senna-Lax by is a Otc medication manufactured, distributed, or labeled by Lake Erie Medical DBA Quality Care Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)
• generally causes a bowel movement in 6-12 hours

Warnings

Do not use

• laxative products for longer than one week unless directed by a doctor

Do not use

laxative products for longer than one week 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 continues 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 care 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 preferably at bedtime or as directed by a doctor

• Adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
• Children 6 to under 12 yearsof age: 1 tablet once a day: maximum 2 tablets once a day
• Children 2 to under 6 yearsof age ½ tablet once a day: maximum 1 tablet once a day
• Children under 2 years of age: ask a doctor

Other information

• Each tablet contains: Calcium 20 mg 
• Store at room temperature

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil and polyethylene glycol

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Product color may slightly vary

due to natural changes of ingredients.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

M-29 Rev. 04/17 Re-Order No. 700532

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA-LAX 
sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-629(NDC:0904-6522)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	1122;1122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55700-629-10	10 in 1 CARTON	05/25/2018
1		1 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	05/25/2018

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	relabel(55700-629)