DailyMed - SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

NDC Code(s): 16103-378-07, 16103-378-08, 16103-378-11
Packager: Pharbest Pharmaceuticals, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 31, 2024

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Active Ingredients (in each tablet)
Sennosides from Senna Concentrate 8.6mg - Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg
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Purpose
Laxative - Stool Softner

Laxative

Stool Softner

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Uses
relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
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Warnings
Do not use - laxative products for longer than 1 week unless directed by a doctor - if you are taking mineral oil, unless directed by a doctor - Ask a doctor before use if you have - stomach ...
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are taking mineral oil, 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 continues over a period of 2 weeks
Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.

If pregnant or breast feeding,

ask a healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

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Directions

take preferably at bedtime or as directed by a doctor - age - starting dosage - maximum dosage - Adults and children 12 years and over - 2 tablets once a day - 4 tablets twice a ...

Other information
each tablet contains 10 mg of calcium, sodium 5 mg - store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)
- each tablet contains 10 mg of calcium, sodium 5 mg
- store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)
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Inactive ingredients
crosscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium ...

crosscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide
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Questions or comments?
(866) 562-2756 Mon-Fri 8 AM to 4 PM EST

(866) 562-2756 Mon-Fri 8 AM to 4 PM EST
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PRINCIPAL DISPLAY PANEL
PHARBEST - NDC 16103-378-07 - Manufactured in the USA - *Compare to the active ingredients in Senokot-S® SENNA-S - Sennosides 8.6mg & Docusate Sodium 50mg - Natural Vegetable ...

PHARBEST

NDC 16103-378-07

Manufactured in the USA

*Compare to the active ingredients in Senokot-S®

SENNA-S

Sennosides 8.6mg &

Docusate Sodium 50mg

Natural Vegetable Laxative

Ingredient Plus Stool Softner

60 TABLETS

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INGREDIENTS AND APPEARANCE

Product Information

SENNA-S sennosides 8.6mg and docusate sodium 50mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16103-378
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (ORANGE COLOR)	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH32
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:16103-378-07	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2018
2	NDC:16103-378-11	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2018
3	NDC:16103-378-08	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/21/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	11/05/2018

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(16103-378) , analysis(16103-378) , pack(16103-378) , label(16103-378)

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age	starting dosage	maximum dosage
Adults and children 12 years and 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

Published Date (What is this?)	Version	Files
Jan 1, 2025	2 (current)	download
Feb 25, 2019	1	download

	RxCUI	RxNorm NAME	RxTTY
1	998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN
2	998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD
3	998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY

Label: SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	16103-378-07
2	16103-378-08
3	16103-378-11

Label: SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

Number of versions: 2

SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

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SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.