FDA Label for Senna Plus
View Indications, Usage & Precautions
Senna Plus Product Label
The following document was submitted to the FDA by the labeler of this product Remedyrepack Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not exceed 8 tablets in 24 hours
| Age
| Starting Dose
| Maximum Dose
|
|---|---|---|
| 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 temperature
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, triacetin
Package Label.Principal Display Panel
DRUG: Senna Plus
GENERIC: Sennosides and Docusate Sodium
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-1590-0
COLOR: yellow
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: CPC490
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- DOCUSATE SODIUM 50mg in 1
- SENNOSIDES 8.6mg in 1
- CELLULOSE, MICROCRYSTALLINE
- SODIUM BENZOATE
- FD&C YELLOW NO. 6
- SODIUM LAURYL SULFATE
- FD&C YELLOW NO. 5
- TITANIUM DIOXIDE
- STARCH, CORN
- STEARIC ACID
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
- CROSCARMELLOSE SODIUM
- HYPROMELLOSES
- MAGNESIUM SILICATE
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOLS
- MINERAL OIL
- TRIACETIN
INACTIVE INGREDIENT(S):
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