OTC Medication Information: Laxative

LAXATIVE- sennosides tablet, film coated
L.N.K. International, 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.

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

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

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.

Directions

  • do not take more than directed
  • 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

Other information

  • each tablet contains: calcium 35 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY
+PLUS

NDC 50844-773-08

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

MAXIMUM STRENGTH
LAXATIVE
Sennosides USP, 25 mg
Stimulant Laxative

24
Tablets

Gentle, Dependable
Constipation Relief

ACTUAL SIZE

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

*This product is not manufactured or distributed by GSK Consumer
Healthcare SARL, owner of the registered trademark ex•lax
Maximum Strength. 50844 ORG082177308

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

Quality Plus 44-773
(click image for full-size original)

Quality Plus 44-773

LAXATIVE sennosides tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-773
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES (SENNOSIDES) SENNOSIDES 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1 ALUMINUM LAKE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50844-773-08 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50844-773-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 06/18/2022
Labeler — L.N.K. International, Inc. (038154464)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (50844-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (50844-773), pack (50844-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (50844-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (50844-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (50844-773)

Revised: 06/2022 L.N.K. International, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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