Laxative Pills description, usages, side effects, indications, overdosage, supplying and lots more!

Laxative Pills

Premier Value (Chain Drug Consortium, LLC)
P and L Development of New York Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

 relief of occasional constipation (irregularity). This product generally produces a bowel movement within 6 to 12 hours.

Warnings

Do not use

  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  •  you have rectal bleeding
  •  you fail to have a bowel movement after use

These may be signs of a serious condition.

If pregnant or breast-feeding,

 ask a health care professional before use.

Keep out of reach of children

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

Directions

  adults and children 12 years of age and older   take 2 tablets once or twice daily with a glass of water
  children 6 to under 12 years of age   take 1 tablet once or twice daily with a glass of water
  children under 6 years of age   consult a doctor

Other information

  • each tablet contains: calcium 40 mg/tablet
  • each tablet contains: magnesium 10 mg/tablet
  • each tablet contains: sodium 3 mg/tablet VERY LOW SODIUM 
  • store at 15º-30ºC (59º-86ºF)
  • keep in a dry place
  • do not expose to excessive heat

Inactive ingredients

acacia, anhydrous lactose*, 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, isopropyl alcohol*, kaolin, Lake Brilliant Blue FCF*, magnesium stearate, malto dextrin*, microcrystalline cellulose, Opacode Black S-1-17823*, Opagloss 6000P*, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, tartaric acid*, and titanium dioxide.

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH EX-LAX®

Maximum Strength Laxative Pills

Sennosides USP, 25 mg

For Maximum Relief of Constipation

Tablets

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD., SUITE 101

BOCA RATON, FL  33431

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

**This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Ex-Lax®.

Product Label

Product Label
Sennosides USP 25 mg

Laxative Pills

Sennosides TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-216
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SENNOSIDES SENNOSIDES 25 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
CALCIUM SULFATE ANHYDROUS
carnauba wax
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 1
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
KAOLIN
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
STARCH, CORN
SHELLAC
SODIUM LAURYL SULFATE
STEARIC ACID
SUCROSE
talc
titanium dioxide
ANHYDROUS LACTOSE
ISOPROPYL ALCOHOL
maltodextrin
tartaric acid

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm TCL083;S25 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:68016-216-00 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2012-12-31


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