Senna tablet, coated

Otc - active ingredient section

Each tablet contains: Sennosides 8.6 mg

Otc - keep out of reach of children section

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Otc - purpose section


PURPOSE: LAXATIVE

Indications & usage section

Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

Dosage & administration section

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.

Adults and children 12 years and over - starting dosage: 2 tablets once a day Maximum dosage: 4 tablets twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a day

Children 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a day

Children under 2 years - ask a doctor

Warnings section

WARNINGS:

Do not uselaxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you haveabdominal pain, nausea, vomiting, or noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Laxatives might affect how other drugs work. Take this product 2 or more hours before or after other drugs.

Stop use and ask a doctor if you haverectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be signs of a serious condition.

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

Inactive ingredient section

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

Ingredients and appearance - Product information

Senna tablet, coated- Sennosides

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 48433-301
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Sennosides a and b ( UNII: 1B5FPI42EN)( Sennosides a and b - UNII: 1B5FPI42EN ) 8.6 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Mineral oil ( UNII: T5L8T28FGP)
Calcium phosphate, dibasic, dihydrate ( UNII: O7TSZ97GEP)

Product Characteristics

Color brown Size 9 mm
Shape ROUND Score 1
Imprint Code TCL080

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part334 USA

Labeler - Safecor Health, LLC( 828269675)

Establishment

Name ID/FEI Business Operations
Safecor Health, LLC 828269675 REPACK( 48433-301)

Package label.principal display panel