VALUMEDS NATURAL LAXATIVE- sennosides tablet, film coated

VALUMEDS NATURAL LAXATIVE by

Drug Labeling and Warnings

VALUMEDS NATURAL LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779 

PRINCIPAL DISPLAY PANEL

*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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0031
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0031-1	1 in 1 CARTON	03/10/2020
1		100 in 1 BOTTLE; 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	03/10/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LTD.		915664486	manufacture(68210-0031)