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Senna

LLC Federal Solutions




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active Ingredient (in each teaspoonful)
Sennosides 8.8 mg

Purpose

Purpose
Laxative

Uses

Uses
relieves occasional constipation (irregularity), generally produces bowel movement in 6-12 hours

Warnings

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

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. These may indicate a serious condition.

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

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

Directions
Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

age starting dose maximum dosage
adults and children 12 years and older 2 - 3 teaspoons once a day 3 teaspoons twice a day
children 6 to under 12 years 1 - 1 1/2 teaspoons once a day 1 1/2 teaspoons twice a day
children 2 to under 6 years 1/2 - 3/4 teaspoon once a day 3/4 teaspoon twice a day
children under 2 years ask a doctor ask a doctor

Other information

  • avoid excessive heat
  • store at room temperature 15°- 30°C (59°- 86°F)

Inactive ingredients
cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Questions? Call 1-855-333-6337
To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801
Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-289-05
SENNA SYRUP
(STANDARDIZED EXTRACT OF SENNA FRUIT)
DELIVERS 5 mL
CONTAINING:
SENNOSIDES 8.8 mg
ALCOHOL FREE
NATURAL CHOCOLATE FLAVOR
SHAKE WELL
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132
Senna

Senna

SENNOSIDES A AND B SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:24451-289(NDC:0904-6289)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SENNOSIDES A AND B SENNOSIDES A AND B 8.8 mg

Inactive Ingredients

Ingredient Name Strength
COCOA
METHYLPARABEN
propylene glycol
PROPYLPARABEN
water
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 CUP, UNIT-DOSE
2 10 in 1 CUP, UNIT-DOSE
3 NDC:24451-289-10 100 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-08-12


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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