Cdma Fiber Therapy Tablet
FDA Label NDC 63868-166

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Cdma Fiber Therapy (NDC 63868-166). 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 active ingredient (in each caplet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Caplet)

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Caplet)

Methylcellulose 500mg

Purpose

Bulk-forming fiber laxative (a non-allergenic fiber)

Uses

helps restore and maintain regularity
relieves constipation (irregularity)
for constipation associated with other bowel disorders like IBS when recommended by a doctor.
generally produces a bowel movement in 12 -72 hours.

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

a sudden change in bowel habits that persists over a period of two weeks
abdominal pain, nausea or vomiting

Stop Use And Ask A Doctor If

Constipation lasts more than 7 days
you have rectal bleeding
These could be signs of a serious condition.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

Take this product (child or adult dose) with at least 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 of age and over	start with 2 caplets. Increase as needed up to 6 times per day.	Do not exceed 12 caplets per day
Children 6-11 years of age	Start with 1 caplet. Increase as needed up to 6 times per day	Do not exceed 6 caplets per day
children under 6 years of age	Consult a physician	Consult a physician

Other Information

each caplet contains: appx. 18 mg of calcium
store at below 77° F (25°C)
protect contents from humidity
keep tightly closed

Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive Ingredients

adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polysorbate 80, silica.

Do not use if printed seal under cap is torn or missing.