SENNA PLUS- sennosides and docusate sodium tablet
REMEDYREPACK INC.

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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Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 6 to 12 hours

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you -have abdominal pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could 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 7 mg

• store at room temperature

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

DRUG: Senna Plus

GENERIC: Sennosides and Docusate Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-675-02

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: CPC490

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

DOCUSATE SODIUM 50mg in 1
SENNOSIDES 8.6mg in 1

INACTIVE INGREDIENT(S):

CELLULOSE, MICROCRYSTALLINE
SODIUM BENZOATE
FD&C YELLOW NO. 6
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 5
TITANIUM DIOXIDE
STARCH, CORN
STEARIC ACID
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM SILICATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
MINERAL OIL
TRIACETIN

Remedy_Label

SENNA PLUS
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52125-675(NDC:57896-455)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC490
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52125-675-02	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/19/2013	09/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/19/2013	09/20/2018

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2018

Document Id: 791463b1-5465-cd0d-e053-2a91aa0a3a8b

Set id: 8adc1cd7-0b18-4231-a78e-821e5200e5c6

Version: 8

Effective Time: 20181025

REMEDYREPACK INC.