FDA Label for Sennosides
View Indications, Usage & Precautions
Sennosides 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.
Drug Facts
Active ingredient (in each tablet)
Sennosides 8.6 mg
Otc - Purpose
Purpose
Laxative
Uses
■ relieves occasional constipation (irregularity)
■ generally produces a bowel movement in 6-12 hours
Otc - Do Not Use
Do not use
■ laxative products for longer than 1 week unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
■ stomach pain
■ nausea
■ vomiting
■ noticed a sudden change in bowel habits that continues over a period of 2 weeks
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
Directions
■ take preferably at bedtime or as directed by a doctor
Age | Starting Dosage | Maximum Dosage |
adults and children 12 years of age and over | 2 tablets once a day | 4 tablet twice a day |
children 6 to under 12 years | 1 tablets once a day | 2 tablets once a day |
children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 25 mg
- each tablet contains: sodium 1 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredient
croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc
Questions Or Comments?
Call 1-800-231-4670 Monday-Friday 9AM-5PM EST
Other
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Package Label.Principal Display Panel
DRUG: Sennosides
GENERIC: Sennosides
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-3387-0
NDC: 70518-3387-1
NDC: 70518-3387-2
NDC: 70518-3387-3
COLOR: brown
SHAPE: ROUND
SCORE: No score
SIZE: 9 mm
IMPRINT: 1122;1122
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 100 in 1 BOX
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 100 in 1 BOX
ACTIVE INGREDIENT(S):
- SENNOSIDES 8.6mg in 1
- POLYETHYLENE GLYCOL 400
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CROSCARMELLOSE SODIUM
- LIGHT MINERAL OIL
- TALC
- MALTODEXTRIN
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
INACTIVE INGREDIENT(S):
* Please review the disclaimer below.