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Soluble fiber - Medication Information

Product NDC Code 41163-288
Drug Name

Soluble fiber

Type Brand
Active Ingredients
Methylcellulose (4000 cps) 500 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 198750
Application Number part334
Labeler Name Supervalu Inc.
Packages
Package NDC Code Description
41163-288-16 100 tablet in 1 bottle (41163-288-16)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT (in each caplet) Methylcellulose 500 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 & children 12 years & over 2 caplets up to 6 times daily children 6 to 11 years 1 caplet up to 6 times daily children under 6 years ask a doctor ask a doctor
AGE DOSE MAXIMUM DOSE
adults & children 12 years & over 2 caplets up to 6 times daily
children 6 to 11 years 1 caplet up to 6 times daily
children under 6 years ask a doctor ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow no.6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulfate.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
USE(S) relieves occasional constipation to help restore and maintain regularity generally produces a bowel movement in 12-72 hours

Purpose

Information about the drug product’s indications for use.
PURPOSE Bulk-forming laxative

Spl product data elements

Usually a list of ingredients in a drug product.
Soluble Fiber Methylcellulose METHYLCELLULOSE (4000 CPS) METHYLCELLULOSE (4000 CPS) ANHYDROUS CITRIC ACID SILICON DIOXIDE CROSPOVIDONE, UNSPECIFIED FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM BICARBONATE SODIUM LAURYL SULFATE SODIUM CHLORIDE G188

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL NDC 41163-288-16 Compare to Citrucel Caplets active ingredient* EQUALINE soluble fiber caplets methylcellulose 500 mg bulk forming laxative gently relieves constipation 100 Caplets 188

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
STOP USE AND ASK DOCTOR IF rectal bleeding occurs you fail to have a bowel movement after use These could be signs of a serious condition

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
WHEN USING THIS PRODUCT do not use laxative products for a period longer than one week unless directed by a doctor. do not use if you are on a low salt diet unless directed by a doctor.

Storage and handling

Information about safe storage and handling of the drug product.
OTHER INFORMATION each caplet contains: sodium 10 mg store below 25 o C (77 o F) protect contents from moisture keep tightly closed

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API