SENNA-LAX- sennosides tablet
Qualitest Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Senna-Lax

ACTIVE INGREDIENTS (IN EACH TABLET)

Sennosides 8.6 mg

PURPOSE

Laxative

USES

for relief of occasional constipation and irregularity
this product produces a bowel movement in 6 to 12 hours

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 if you are

taking a prescription 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 longer than 1 week unless directed by a doctor

Stop use and ask a doctor

rectal bleeding or failure to have a bowel movement occur 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.

DIRECTIONS

Take preferably at bedtime or as directed by doctor
If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

Age	Starting dosage	Maximum dosage
Adults and children over 12 years	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	consult a doctor

OTHER INFORMATION

each tablet contains: calcium 50 mg
store at 20°-25°C (68°-77°F)

You may report serious side effects to: 1-888-952-0050.

INACTIVE INGREDIENTS

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose

PRINCIPAL DISPLAY PANEL

LB1375

Senna Lax

SENNA-LAX
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0603-0282
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code	AZ217
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0603-0282-21	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/1996	11/26/2018
2	NDC:0603-0282-32	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/1996	11/26/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/27/1996	11/26/2018

Labeler - Qualitest Pharmaceuticals (011103059)

Registrant - Qualitest Pharmaceuticals (011103059)

Revised: 11/2018

Document Id: 13be4147-756d-4499-b9a1-9ce88efa69ab

Set id: d7dfb02a-41b2-4b0a-9bf6-debf1e69c883

Version: 6

Effective Time: 20181127

Qualitest Pharmaceuticals