FDA Label for Sunmark Fiber Laxative
View Indications, Usage & Precautions
Sunmark Fiber Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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.
Active Ingredient (In Each Caplet)
Methylcellulose 500 mg
Purpose
Bulk-forming laxative
Otc - Keep Out Of Reach Of Children
Uses
- helps restore and maintain regularity and relieves constipation (irregularity)
- in the treatment of constipation associated with other bowel disorders when recommended by a doctor
Warnings
Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
Ask A Doctor Before Use If You Have
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits that persists over a period of 2 weeks
- sensitivity to any of the ingredients
When Using This Product
- do not exceed recommended maximum dose unless directed by a doctor
- do not use laxative products for a period longer than one week unless directed by a doctor
Stop Use And Ask A Doctor If
- rectal bleeding occurs
- you fail to have a bowel movement after use
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a poison control center right away.
Directions
This product generally produces effect in 12-72 hours
- take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid
- taking this product without enough liquid may cause choking, see choking warning
Age | Dose | Maximum Dose |
adults and children over 12 years | 2 caplets | up to 6 times daily |
children (6 to 12 years) | 1 caplet | up to 6 times daily |
children under 6 years | ask a doctor | ask a doctor |
Other Information
- each caplet contains: sodium 10 mg
- store at room temperature 15o-30oC (59o-86oF)
- protect contents from moisture
- keep tightly closed
- tamper evident: Do not use if printed seal under cap is torn or missing
Inactive Ingredients
citric acid, colloidal silicon dioxide, crospovidone, FD and C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate
Principal Display Panel
Sunmark
compare to Citrucel caplets active ingredient
fiber laxative
bulk-forming laxative
Daily source of 100% soluble fiber
methylcellulose 500 mg
The fiber with no excess gas
dietary fiber supplement
100 caplets
Fiber laxative image1
Fiber laxative image 2
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