191r Rite Aid 11822 7851 Natural Laxative 500 Ct

191r Rite Aid 11822 7851 Natural Laxative 500 Ct
SPL v2
SPL
SPL Set ID ad5086eb-97d3-300a-e053-2a95a90a15cc
Route
ORAL
Published
Effective Date 2020-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-18

Description

Active ingredient (in each tablet) Sennosides 8.6 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

Directions

  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

age

starting

dosage

maximum

dosage

adults and children 12 years and over 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

Description

Active ingredient (in each tablet) Sennosides 8.6 mg

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 if you have rectal bleeding or fail to have a bowel movement after use of 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 movements that continues over a period of 2 weeks
Section 50570-1

Do not use

laxative products for longer than 1 week unless directed by a doctor

Section 51727-6

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Laxative

Section 55106-9

Active ingredient (in each tablet)

Sennosides 8.6 mg

Section 60561-8

Other information

  • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Directions

  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

age

starting

dosage

maximum

dosage

adults and children 12 years and over 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

Warnings and Precautions (34071-1)

Warnings

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 if you have rectal bleeding or fail to have a bowel movement after use of 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 movements that continues over a period of 2 weeks
Section 50570-1 (50570-1)

Do not use

laxative products for longer than 1 week unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Laxative

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Sennosides 8.6 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Advanced Ingredient Data


Raw Label Data

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