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Drug Facts
Distributed By: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket RI 02895
CVS.com
1-800-SHOP CVS
Cvs
FDA Label NDC 59779-535
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs (NDC 59779-535). 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 other, active ingredient (in each packet), purpose, uses, choking, allergy alert, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Packet)
Psyllium husk approximately 3.4 g
Purpose
Fiber therapy for regularity
Uses
- for relief of occasional constipation (irregularity)
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.
Allergy Alert
This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.
Otc - Ask Doctor
Ask a doctor before use if you have
- a sudden change in bowel habits persisting for 2 weeks
- abdominal pain, nausea or vomiting
Otc - Stop Use
Stop use and ask a doctor if
- constipation lasts more than 7 days
- rectal bleeding occurs
These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a doctor or a Poison Control Center right away. (1-800-222-1222)
Directions
Put one packet into an empty glass. Mix 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older: | 1 packet in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. |
Bulk forming fibers, like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
Other Information
- each packet contains: potassium 30 mg; sodium 194.0 mg
- PHENYLKETONURICS: CONTAINS PHENYLALANINE, 29.0 mg per teaspoon
- store at room temperature tightly closed to protect from humidity
- do not use if printed package is torn or punctured
- contains a 100% natural, therapeutic fiber
Inactive Ingredients
anhydrous citric acid, aspartame, flavors, sodium bicarbonate, sucralose, yellow no 6.
Principal Display Panel
Natural Daily Fiber Effervescent
Smooth Dissolving
100% Natural Psyllium Husk Fiber Supplement
Compare to the active ingredient in Metamucil® MultiHealth Fiber
Sugar Free
Therapy for regularity as part of a healthy lifestyle
Promotes digestive health
Helps lower cholesterol to promote heart health
Orange
Naturally and Artificially Flavored
30 Packets
Cvs Daily Fiber Effervescent (280eafc2 Bfdf 4bce A24c C55b07ff9d87 01)
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