195r Sennosides Tablets Usp 25 Mg Sugar Coated Off-white

195r Sennosides Tablets Usp 25 Mg Sugar Coated Off-white
SPL v4
SPL
SPL Set ID 74a627fc-00e5-eb78-e053-2991aa0abacc
Route
ORAL
Published
Effective Date 2018-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (25 mg)
Inactive Ingredients
Iron Oxides Povidone Shellac Titanium Dioxide Ferric Oxide Yellow Calcium Cation Carnauba Wax Starch, Corn Croscarmellose Stearic Acid Ferrosoferric Oxide Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Kaolin Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol 400 Raw Sugar Talc Acacia Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL083 Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-30

Description

Active Ingredients (in each tablet) Sennosides USP, 25 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • Relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Dosage and Administration

Directions

  • swallow tablet (s) with a glass of water.
  • swallow tablet (s) whole, do not crush, break or chew.

    adults and children 12 years of age and older

    2 tablets once or twice daily

    children 6 to under 12 years of age

    1 tablet once or twice daily

    children under 6 years of age

    ask a doctor

Description

Active Ingredients (in each tablet) Sennosides USP, 25 mg

Section 50565-1

Keep out of the 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

  • rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
Section 50567-7

When using this product

  • do not use for a period longer than 1 week
Section 50568-5

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.

Section 50569-3

Ask a doctor before use if you have

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Section 50570-1

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Section 51727-6

Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

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

Stimulant Laxative

Section 55106-9

Active Ingredients (in each tablet)

Sennosides USP, 25 mg

Section 60561-8

Other information

  • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
  • store between 20°-25°C (68°-77°F)
195r Lax Time (sennosides) 25 Mg


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Directions

  • swallow tablet (s) with a glass of water.
  • swallow tablet (s) whole, do not crush, break or chew.

    adults and children 12 years of age and older

    2 tablets once or twice daily

    children 6 to under 12 years of age

    1 tablet once or twice daily

    children under 6 years of age

    ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of the 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

  • rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product

  • do not use for a period longer than 1 week
Section 50568-5 (50568-5)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Section 50570-1 (50570-1)

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

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

Stimulant Laxative

Section 55106-9 (55106-9)

Active Ingredients (in each tablet)

Sennosides USP, 25 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
  • store between 20°-25°C (68°-77°F)
195r Lax Time (sennosides) 25 Mg (195R Lax-Time (Sennosides) 25 mg)


Advanced Ingredient Data


Raw Label Data

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