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Drug Facts
INDIVIDUAL PACKETS SEALED FOR YOUR PROTECTION
DIST. BY Atlantic Biologicals
Miami, FL 33179
Metamucil Powder
FDA Label NDC 17856-1124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Metamucil (NDC 17856-1124). 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 (5.8 g)), purpose, uses, • choking:, allergy alert:, ask a doctor before useif you have, ask a doctor or pharmacist before use if you, 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 (5.8 G))
Psyllium husk approximately 3.4 g
Purpose
Fiber laxative
Uses
- for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
• 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 reactions in people sensitive to inhaled or ingested psyllium.
Ask A Doctor Before Useif You Have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits persisting for 2 weeks
Ask A Doctor Or Pharmacist Before Use If You
are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop Use And Ask A Doctorif
• constipation lasts more than 7 days
• rectal bleeding occurs
• you fail to have a bowel movement
These may be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, contact a doctor or a Poison Control Center right away.
Directions
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. For a lighter flavor experience and thinner drink, use more water.
| 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. |
| 6 – 11 yrs. | 1/2 packet in 8 oz of liquid, up to 3 times daily |
| Under 6 yrs. | Consult a doctor |
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 (5.8 g) contains:potassium 30 mg; sodium 5 mg
- PHENYLKETONURICS: CONTAINS PHENYLALANINE,25 mg per packet
- Store below 86° F (30° C)
Inactive Ingredients
aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor
Questions?
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch/report.ht
Principal Display Panel
MetaMUCIL
PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY
50 Pouches
4-in-1 FIBER
HELPS SUPPORT:
Appetite Control*
Heart Health by Lowering Cholesterol†
Healthy Blood Sugar Levels*
Digestive Health *
SUGAR-FREE
not a low calorie food
†See back for information about soluble fiber and heart disease
ORANGE naturally and artificially flavored
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
* Please review the disclaimer below.
