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Product NDC Code | 49035-756 | ||||
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Drug Name | Equate fiber therapy |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 198750 | ||||
Application Number | M007 | ||||
Labeler Name | Wal-Mart Stores,Inc., | ||||
Packages |
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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 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica. Do not use if printed seal under cap is torn or missing.
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.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 ▪ sensitivity to any of the ingredients ▪ a sudden change in bowel habits that persists over a period of 2 weeks When using this product ▪ do not exceed recommended maximum daily 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.
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.equate Fiber Therapy Methylcellulose METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S) ADIPIC ACID CALCIUM CARBONATE CROSPOVIDONE (120 .MU.M) FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 SILICON DIOXIDE Light orange Caplet RP122
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 49035-756-10 Compare to Citrucel® Caplets Active Ingredients* equate ® Fiber Therapy Methylcellulose • 100% Soluble Fiber for Controlled Regularity • Easy to take Caplets 500 mg 100 CAPLETS GLUTEN FREE Satisfaction guaranteed-for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 ©Wal-Mart Stores, Inc. *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Citrucel® Caplets. equate Fiber Therapy Caplets 100 Caplets
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information ▪ each caplet contains : appx. 18 mg of calcium ▪ store at room temperature 15°-30° C( 59°-86° F) ▪ protect contents from moisture ▪ keep tightly closed
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 ▪ sensitivity to any of the ingredients ▪ a sudden change in bowel habits that persists over a period of 2 weeks When using this product ▪ do not exceed recommended maximum daily 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.
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 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.
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 exceed recommended maximum daily dose unless directed by a doctor ▪ do not use laxative products for a period longer than one week unless directed by a doctor
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. Ask a doctor before use if you have ▪ abdominal pain, nausea or vomiting ▪ sensitivity to any of the ingredients ▪ a sudden change in bowel habits that persists over a period of 2 weeks When using this product ▪ do not exceed recommended maximum daily 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.
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