Polysaccharide-Iron

Manufacturer: Advance Pharmaceutical Inc.
Effective date: 2019-12-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:02:18

Label at a glance#

ProductPolysaccharide-Iron

Active ingredientIRON

Label structure11 sections

Indications and uses

Iron Supplement

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Iron (as Polysaccharide Iron) 150 mg

Purpose

OTC - PURPOSE SECTION

Iron Supplement

Uses

INDICATIONS & USAGE SECTION

Iron Supplement

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

e71c431d-figure-01

NDC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198806	polysaccharide iron complex (as iron) 150 MG Oral Capsule	PSN	2
198806	polysaccharide iron complex 150 MG Oral Capsule	SCD	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17714-077-01	2021-01-29	C162847	48780-1	ba0f9c33-2b4e-a910-e053-dadaa90a0b85	Polysaccharide-Iron Complex 150 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17714-077-01	Polysaccharide-Iron	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17714-077	POLYSACCHARIDE-IRON CAPSULE [ADVANCE PHARMACEUTICAL INC.]	2	Legacy NDC, 1 package rows	20191224_a42168eb-180e-4b67-b8fd-641b0af32ff3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Polysaccharide-Iron
CELLULOSE, MICROCRYSTALLINE
GELATIN
CROSCARMELLOSE SODIUM
CITRIC ACID MONOHYDRATE
STEARIC ACID
TITANIUM DIOXIDE
D&C YELLOW NO. 10
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6
FD&C RED NO. 40
FD&C BLUE NO. 1
IRON

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17714-077	17714-077-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
GELATIN	2G86QN327L	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
IRON	E1UOL152H7	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9a63cc06-6032-4c5a-e053-2a95a90aa3a3			a42168eb-180e-4b67-b8fd-641b0af32ff3	2019-12-23	Warnings	Exact identifier spl id: 9a63cc06-6032-4c5a-e053-2a95a90aa3a3 spl set id: a42168eb-180e-4b67-b8fd-641b0af32ff3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.