Valumeds Natural Laxative (Sennosides) Tablet, Film Coated [Spirit Pharmaceuticals Llc] -

VALUMEDS NATURAL LAXATIVE (SENNOSIDES) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]
PDF | XML

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each tablet)

Sennosides 8.6 mg
Purpose

Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
Warnings
Do not use
- laxative products for longer than 1 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 lasts over 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 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

Age	Starting Dosage	Maximum Dosage
adults and children 12 years of age or over	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	ask a doctor	ask a doctor

Other information
- each tablet contains: calcium 24 mg and sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid
Questions or comments?

Call 1-888-333-9792
SPL UNCLASSIFIED SECTION

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL - 8.6 mg Tablet Bottle
VALUMEDS

*COMPARE TO THE ACTIVE

INGREDIENT IN SENOKOT®

Natural Laxative
- Sennosides USP, 8.6 mg
  Laxative
Gentle, Overnight Relief
Natural Vegetable Laxative Ingredient

Actual Size

100 TABLETS

INGREDIENTS AND APPEARANCE

VALUMEDS NATURAL LAXATIVE
sennosides tablet, film coated

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-0310-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2017
2	NDC:68210-0310-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2017
3	NDC:68210-0310-8	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/18/2017

Labeler - Spirit Pharmaceuticals LLC (179621011)

Name	Address	ID/FEI	Business Operations
Establishment
ELYSIUM PHARMACEUTICALS LTD.		863182240	manufacture(68210-0310)

View All Sections

Medic