FERROUS SULFATE

Manufacturer: LLC Federal Solutions | Silarx Pharmaceuticals, Inc
Effective date: 2013-08-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:39:58

Label at a glance#

ProductFERROUS SULFATE

Active ingredientFERROUS SULFATE

Label structure13 sections

Boxed warning

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Supplemental Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL) (one teaspoonful)
Ferrous Sulfate 220 mg (equivalent to 44 mg of elemental Iron)

OTC - PURPOSE SECTION

Purpose
Iron Supplement

INDICATIONS & USAGE SECTION

Uses
Iron supplements are used to treat or prevent low blood levels of iron, such as for anemia or during pregnancy

WARNINGS SECTION

Warnings
Iron containing products should only be taken for very specific reasons and only under the advice and supervision of a doctor. Consult your doctor, for guidance for iron supplementation.

Do not exceed recommended dosage.

BOXED WARNING SECTION

Warning:
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

OTC - DO NOT USE SECTION

Do NOT use if

you are allergic to any ingredient in Ferrous Sulfate Elixir
you have high levels of iron in your blood

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if

pregnant, planning to become pregnant, or are breast-feeding
you are taking any prescription or over-the-counter medicines

Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron containing medications may occasionally cause constipation or diarrhea, and may cause temporary staining of the teeth. Mixing Ferrous Sulfate Elixir with water or fruit juice may help to decrease the effects.

Do not take Ferrous Sulfate Elixir within 1 hour before or 2 hours after antacids, eggs, milk, milk byproducts, coffee, or tea.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions
Do not exceed recommended dosage. Do not mix with milk, milk byproducts, or wine-based vehicles.
Adults 1 teaspoonful daily or as directed by a doctor
Children under 12 years Consult a doctor

INACTIVE INGREDIENT SECTION

Other ingredients
purified water, sucrose, alcohol (5%), sorbitol solution, propylene glycol, citric acid, lemon flavor, sodium benzoate, ascorbic acid, FD&C yellow no. 6, saccharin sodium.

OTHER SAFETY INFORMATION

Other information

Store in tight, light-resistant container at room temperature

Manufactured by: Silarx Pharmaceuticals, Inc.
                                    19 West Street
                                    Spring Valley, NY 10977
Distributed by:         LLC Federal Solutions
          14 NE 1st Ave.
                                    Miami, FL 33132
Rev 108-00 07/2013

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-002-05
FERROUS SULFATE
ELIXIR
220 mg / 5 mL
(EQUIVALENT TO 44 mg IRON)
DELIVERS 5 mL
LEMON FLAVOR
ALCOHOL 5%
Exp: 00/00/00 Lot # 00000

Mfg By: Silarx Pharmaceuticals, Inc.
Spring Valley, NY 10977 USA
Dist. By: LLC Federal Solutions
Miami, FL 33132

product label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24451-002-05	2020-01-07	C162847	48780-1	9855d018-dcac-cd31-e053-dbdaa90ab51a	b836e241-e47c-405b-b1e0-7a93fc809a32
24451-002-05	2019-11-27	C162847	48780-1	9855d018-dcac-cd31-e053-dbdaa90ab51a	b836e241-e47c-405b-b1e0-7a93fc809a32

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FERROUS SULFATE	ACTIVE INGREDIENT	39R4TAN1VT	3
FERROUS CATION	ACTIVE MOIETY	GW89581OWR	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

FERROUS SULFATE
FERROUS CATION
WATER
SUCROSE
ALCOHOL
SORBITOL
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
ASCORBIC ACID
FD&C YELLOW NO. 6
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24451-002	24451-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FERROUS SULFATE	39R4TAN1VT	ACTIM
WATER	059QF0KO0R	IACT
SUCROSE	C151H8M554	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 448 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LIQUID / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CONCENTRATE / ORAL	6 mg/1ml		Exact identifier — unii candidate 25 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SUSPENSION, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION / INTRAMUSCULAR		192 mg	Exact identifier — unii candidate 25 equally ranked IID candidates

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
38d13c4f-3921-4676-827d-146202172021			b836e241-e47c-405b-b1e0-7a93fc809a32	2013-08-20	Boxed warning, Warnings	Exact identifier spl id: 38d13c4f-3921-4676-827d-146202172021 spl set id: b836e241-e47c-405b-b1e0-7a93fc809a32

Reported adverse events (FAERS/openFDA)#

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