Label: NATURAL SENNA LAXATIVE- sennosides tablet
- NDC Code(s): 0761-0790-02
- Packager: Basic Drugs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 17, 2023
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- Active ingredient (in each tablet)
Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask a doctor before use if you have
- noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Ask a doctor or pharmacist before use if you
- are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after
When using this product
- do not use for a period longer than 1 week.
Stop use and ask a doctor if
- rectal bleeding or failure to have a bowel movement occur 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.
- take preferably at bedtime or as directed by a doctor
- If you do not have a confortable bowel movement by the second day, increase dosage by one tablet (do not exceed the maximum dosage) or decrease dose until you are confortable.
adults and children 12 years and over
- take 2 tablets once a day.
- do not take more than 4 tablets twice a day.
children 6 to under 12 years
- take 1 tablet once a day.
- do not take more than 2 tablets twice a day.
children 2 to under 6 years
- take 1/2 tablet once a day.
- do not take more than 1 tablet twice a day.
children under 2 years
- ask a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
NATURAL SENNA LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0761-0790 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color brown Score no score Shape ROUND Size 8mm Flavor Imprint Code AZ217 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0761-0790-02 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/14/2021 Labeler - Basic Drugs, Inc. (052155082)