Label: LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet
- NDC Code(s): 55315-140-03
- Packager: Freds Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Sennosides USP, 25 mgClose
- relief of occasional constipation (irregularity). This product generally produces bowel movement within 6 to 12 hours.
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.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 - 30º C (59º-86º F)
- 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*, titanium dioxide.
*contains one or more of these ingredientsClose
- Questions or Comments?
Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Compare to active ingredient in maximum strength EX-LAX® †
Sennosides USP, 25 mg
natural senna ingredient
for gentle, dependable overnight relief
TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
† This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Ex-Lax®Close
- Product Label
Sennosides, USP 25 mg
- INGREDIENTS AND APPEARANCE
LAXATIVE PILLS MAXIMUM STRENGTH
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-140 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (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 BLUE Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL083;S25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-140-03 2 in 1 CARTON 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/08/2010 Labeler - Freds Inc (005866116) Registrant - P and L Development of New York Corporation (800014821)