sunmark 451

Drug Labeling and Warnings

Drug Details [pdf]

SENNA LAXATIVE- sennosides tablet 
MCKESSON (SUNMARK)

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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sunmark 451

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

• this product generally produces a bowel movement in 6 to 12 hours
• relieves occasional constipation (irregularity)

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you

• have abdominal pain, nausea or vomiting
• have noticed a sudden change in bowel habits that lasts over two weeks

Stop use and ask a doctor if

• you have no bowel movement within 12 hours
• you have rectal bleeding

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

• do not exceed 8 tablets in 24 hours

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor	4 tablets in the morning and 4 tablets at bedtime
children under 12 years	ask a doctor

Other information

• each tablet contains: calcium 20 mg
• store at room temperature 15-30C (59-86F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

package label

Sunmark

Compare to the Active Ingredient in Senokot*

NDC: 49348-165-10

Senna laxative

Natural Vegetable Laxative ingredient

Gentle, overnight relief

sennosides, 8.6 mg

100 Tablets

SENNA LAXATIVE 
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-165
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-165-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/01/2016	11/01/2019

Labeler - MCKESSON (SUNMARK) (177667227)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceuticals, Corp		611196254	repack(49348-165)

Revised: 4/2018

Document Id: 6a86537b-8567-b897-e053-2991aa0afdb5

34390-5

Set id: 3b4dc404-146e-26c0-e054-00144ff8d46c

Version: 2

Effective Time: 20180423

 

MCKESSON (SUNMARK)