SPL v3
SPL
SPL Set ID 69b42f8a-6764-402b-a3d0-781a1f2e3b96
Route
ORAL
Published
Effective Date 2019-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Silicate Magnesium Stearate Mineral Oil Polyethylene Glycol, Unspecified Hypromelloses Fd&c Yellow No. 5 Fd&c Yellow No. 6 Sodium Benzoate Sodium Lauryl Sulfate Starch, Corn Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: CPC490 Shape: round Color: yellow Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-10-25

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
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 51945-4

DRUG: Senna Plus

GENERIC: Sennosides and Docusate Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1590-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: CPC490

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 50mg in 1
  • SENNOSIDES 8.6mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM BENZOATE
  • FD&C YELLOW NO. 6
  • SODIUM LAURYL SULFATE
  • FD&C YELLOW NO. 5
  • TITANIUM DIOXIDE
  • STARCH, CORN
  • STEARIC ACID
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSES
  • MAGNESIUM SILICATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • MINERAL OIL
  • TRIACETIN

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you -have abdominal  pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that  lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could signs of a serious condition.

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

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor

Other Information

each tablet contains: calcium 7 mg

• store at room temperature

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

Active Ingredient (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
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 51945-4 (51945-4)

DRUG: Senna Plus

GENERIC: Sennosides and Docusate Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1590-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: CPC490

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 50mg in 1
  • SENNOSIDES 8.6mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM BENZOATE
  • FD&C YELLOW NO. 6
  • SODIUM LAURYL SULFATE
  • FD&C YELLOW NO. 5
  • TITANIUM DIOXIDE
  • STARCH, CORN
  • STEARIC ACID
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSES
  • MAGNESIUM SILICATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • MINERAL OIL
  • TRIACETIN

Purpose

Stool softener

Laxative

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you -have abdominal  pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that  lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could signs of a serious condition.

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

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor

Other Information (Other information)

each tablet contains: calcium 7 mg

• store at room temperature

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

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