FDA Label for Sennosides 8.6mg

View Indications, Usage & Precautions

Sennosides 8.6mg Product Label

The following document was submitted to the FDA by the labeler of this product Pharmaceutica North America, 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



Sennosides 8.6 mg (in each tablet)


Purpose



Laxative


Uses



• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours


Warnings



Do not use laxative products for longer than 1 week unless directed by a 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

Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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 (1-800-222-1222) right away.


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 tablets twice a day
 children 6 to under 12 years 1 tablet once a day 2 tablets twice 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



store in a dry place at 15° – 30°C (59° – 86°F).


Inactive Ingredients



croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc.


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