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Drug Facts
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Valumeds Natural Laxative
FDA Label NDC 68210-0310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Valumeds Natural Laxative (NDC 68210-0310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Purpose
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
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 lasts over 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| Age | Starting Dosage | Maximum Dosage |
|---|---|---|
| adults and children 12 years of age or 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
- each tablet contains: calcium 24 mg and sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid
Questions Or Comments?
Call 1-888-333-9792
Principal Display Panel - 8.6 Mg Tablet Bottle
VALUMEDS
*COMPARE TO THE ACTIVE
INGREDIENT IN SENOKOT®
Natural Laxative
- Sennosides USP, 8.6 mg
Laxative
Gentle, Overnight Relief
Natural Vegetable Laxative Ingredient
Actual Size
100 TABLETS
* Please review the disclaimer below.
