Polysaccharide-iron
FDA Label NDC 17714-077

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Polysaccharide-iron (NDC 17714-077). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

.

Active Ingredient

(in each capsule)

Iron (as Polysaccharide Iron) 150 mg

Purpose

Iron Supplement

Uses

  • Iron Supplement

Warnings

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause black stools, constipation or diarrhea. If pregnant or breast feeding, ask a health professional before use.

Accidental overdose of Iron containing products is a leading cause of fatal poisoning in children under 6.

DRUG INTERACTION PRECAUSION: Since oral iron products interfere with absorption of tetracycline antibiotics, these products should not be taken within two hours of each other.

Keep Out Of Reach Of Children.

In case of accidental overdose, call a doctor or poison control center immediately.

Directions

Adults only: One capsule daily or as directed by a doctor. Do not exceed recommended dosage.

Other Information

  • store at 15-30 °C (59-86 °F). Do not expose to excessive heat or moisture.

Inactive Ingredients

Microcrystalline Cellulose, geltain, corscarmellose sodium, citric acid anhydrous, stearic acid, titanium dioxide, D&C Yellow #10, sodium lauryl sulfate, FD&C Yellow #6, FD&C Red#40, FD&C Blue #1and white ink

Questions Or Comments

TAMPER RESISTENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Package Label.Principal Display Panel

E71c431d-figure-01 (E71c431d Figure 01)

E71c431d-figure-01 (E71c431d Figure 01)

NDC

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