FDA Label for Vegetable Laxative
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vegetable Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands Llc.. 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.
Otc - Active Ingredient
Active ingredient (in each tablet)
Sennosides 8.6 mg
Otc - Purpose
Purpose
Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
Warnings
Warnings
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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
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 | ½ tablet once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a doctor |
Other Safety Information
Other information
- each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil
Otc - Questions
Questions or comments?1-877-290-4008
Package Label.Principal Display Panel
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