Label: SENNA PLUS - sennosides and docusate sodium tablet
- NDC Code(s): 57896-455-01, 57896-455-06, 57896-455-10
- Packager: Geri-Care Pharmaceutical Corp
- 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)
Docusate Sodium 50 mgClose
Sennosides 8.6 mg
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Do not use for more than 1 week unless directed by a doctor
Ask a doctor before use if you -have abdominal pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could signs of a serious condition.
if pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• do not exceed 8 tablets in 24 hours
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor
- Other information
• each tablet contains: calcium 7 mg
• store at room temperatureClose
- Inactive ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetinClose
- Package Label
Natural Vegetable Laxative
with Stool Softener
Standardized Senna Concentrate
COMPARE TO ACTIVE INGREDIENT
- INGREDIENTS AND APPEARANCE
sennosides and docusate sodium tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57896-455 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM SILICATE MAGNESIUM STEARATE MINERAL OIL POLYETHYLENE GLYCOLS HYPROMELLOSES FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 SODIUM BENZOATE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN Product Characteristics Color yellow Score no score Shape ROUND Size 10mm Flavor Imprint Code CPC490 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-455-01 100 in 1 BOTTLE 2 NDC:57896-455-06 60 in 1 BOTTLE 3 NDC:57896-455-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)