Laxacin Tablets

Laxacin Tablets
SPL v2
SPL
SPL Set ID fe7d4d75-0f8a-1e7d-e053-6394a90afb4d
Route
ORAL
Published
Effective Date 2023-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides A And B (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Dextrose, Unspecified Form Anhydrous Dibasic Calcium Phosphate Fd&c Yellow No. 6 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Benzoate Stearic Acid Titanium Dioxide Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G55 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-19
Description

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Dosage and Administration

Directions

  • take preferably at bedtime or as directed by a doctor

age

starting dose

maximum dose

adults and children 12

years and older

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
Dosage Forms and Strengths

Laxacin tablets are supplied as follows:

Bottles of 100 tablets NDC: 80425-0345-01

Description

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts

Section 42229-5

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Section 44425-7

Other information

  • each tablet contains: calcium 20 mg, sodium 4 mg
  • keep lid tightly closed
  • store at room temperature in a dry place
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Section 50569-3

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
Section 50570-1

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6

Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

Section 51945-4

Section 53413-1

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

Purposes

Stool softener

Laxative

Section 55106-9

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Dosage and Administration (34068-7)

Directions

  • take preferably at bedtime or as directed by a doctor

age

starting dose

maximum dose

adults and children 12

years and older

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
Dosage Forms and Strengths (34069-5)

Laxacin tablets are supplied as follows:

Bottles of 100 tablets NDC: 80425-0345-01

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Section 44425-7 (44425-7)

Other information

  • each tablet contains: calcium 20 mg, sodium 4 mg
  • keep lid tightly closed
  • store at room temperature in a dry place
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Stool softener

Laxative

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.126310 · Updated: 2026-03-14T23:06:38.217628