Laxative: Package Insert and Label Information

LAXATIVE- sennosides tablet, film coated
TOPCO ASSOCIATES LLC

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?

1-888-423-0139

Principal display panel

+TopCare®
health

NDC 76162-773-08

COMPARE TO EX•LAX®
MAXIMUM STRENGTH
ACTIVE INGREDIENT

MAXIMUM STRENGTH
Laxative
SENNOSIDES USP, 25 mg • STIMULANT LAXATIVE

• Senna Ingredient
• Gentle, Dependable Constipation Relief

24 COATED 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.

QUALITY GUARANTEED

50844 ORG082177308

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0522
QUESTIONS? 1-888-423-0139
topcare@topco.comwww.topcarebrand.com

TopCare 44-773
(click image for full-size original)

TopCare 44-773

LAXATIVE sennosides tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-773
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:76162-773-08 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 (76162-773-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 06/18/2022
Labeler — TOPCO ASSOCIATES LLC (006935977)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (76162-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (76162-773), pack (76162-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (76162-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (76162-773)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (76162-773)

Revised: 06/2022 TOPCO ASSOCIATES LLC

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