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

Active Ingredient

Active Ingredients (in each tablet)

Sennosides USP, 25 mg

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 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

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active Ingredients (in each tablet)

Sennosides USP, 25 mg

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

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 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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