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

Active Ingredient

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

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

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

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