MedPath

Laxative

Quality Plus 44-348

Approved
Approval ID

3a996ba7-f221-4453-8afa-69d8ac0a28b9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

L.N.K. International, Inc.

DUNS: 038154464

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sennosides

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50844-348
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sennosides
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (23)

SENNOSIDESActive
Quantity: 25 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Principal Display Panel

QUALITY
** +PLUS**

NDC 50844-348-08

*Compare to active ingredient
in ex•lax® Maximum Strength

MAXIMUM STRENGTH
LAXATIVE
Sennosides USP, 25 mg
Stimulant Laxative

Gentle, Dependable
Constipation Relief

24
** Coated Tablets**

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF
** PACKAGE IS OPENED OR IF BLISTER UNIT**
** IS TORN, BROKEN OR SHOWS ANY SIGNS**
** OF TAMPERING**

Distributed by****
** LNK INTERNATIONAL, INC.**
****60 Arkay Drive
Hauppauge, NY 11788
USA

*This product is not
manufactured or distributed by
GSK Consumer Healthcare S.A.,
owner of the registered
trademark ex•lax® Maximum
Strength.
50844 ORG041934808

![Quality Plus 44-348](/dailymed/image.cfm?name=quality- plus-44-348-1.jpg&id=892243)

Quality Plus 44-348

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Stimulant laxative

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredient (in each tablet)

Sennosides USP, 25 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

Do not use

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have

noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor or pharmacist before use if you are


taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When using this product,

do not use for a period longer than 1 week.

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole; do not crush, break, or chew

adults and children 12 years and over

2 tablets once or twice daily

children 6 to under 12 years

1 tablet once or twice daily

children under 6 years

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/12/2025

Other information

*each tablet contains: calcium 40 mg, magnesium 5 mg

*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

1-800-426-9391

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Laxative - FDA Drug Approval Details