# 21 C.F.R. § 310.518 (2026): Drug products containing iron or iron salts > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_518 ## Section - **Citation:** 21 C.F.R. § 310.518 (2026) - **Heading:** Drug products containing iron or iron salts - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 310 / Subpart E / § 310.518: § 310.518 Drug products containing iron or iron salts. ## Text Drug products containing elemental iron or iron salts as an active ingredient in solid oral dosage form, e.g., tablets or capsules shall meet the following requirements: (a) Labeling. (1) The label of any drug in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source shall bear the following statement: WARNING: Accidental overdose or iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. (2)(i) The warning statement required by paragraph (a)(1) of this section shall appear prominently and conspicuously on the information panel of the immediate container label. (ii) If a drug product is packaged in unit-dose packaging, and if the immediate container bears labeling but not a label, the warning statement required by paragraph (a)(1) of this section shall appear prominently and conspicuously on the immediate container labeling in a way that maximizes the likelihood that the warning is intact until all of the dosage units to which it applies are used. (3) Where the immediate container is not the retail package, the warning statement required by paragraph (a)(1) of this section shall also appear prominently and conspicuously on the information panel of the retail package label. (4) The warning statement shall appear on any labeling that contains warnings. (5) The warning statement required by paragraph (a)(1) of this section shall be set off in a box by use of hairlines. (b) The iron-containing inert tablets supplied in monthly packages of oral contraceptives are categorically exempt from the requirements of paragraph (a) of this section. [68 FR 59715, Oct. 17, 2003] ## Nearby sections - [21 C.F.R. § 310.501 (2026) § 310.501 Patient package inserts for oral contraceptives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_501.md) - [21 C.F.R. § 310.502 (2026) § 310.502 Certain drugs accorded new drug status through rulemaking procedures.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_502.md) - [21 C.F.R. § 310.503 (2026) § 310.503 Requirements regarding certain radioactive drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_503.md) - [21 C.F.R. § 310.509 (2026) § 310.509 Parenteral drug products in plastic containers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_509.md) - [21 C.F.R. § 310.515 (2026) § 310.515 Patient package inserts for estrogens.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_515.md) - [21 C.F.R. § 310.517 (2026) § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_517.md) - [21 C.F.R. § 310.518 (2026) § 310.518 Drug products containing iron or iron salts.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_518.md) - [21 C.F.R. § 310.519 (2026) § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_519.md) - [21 C.F.R. § 310.527 (2026) § 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_527.md) - [21 C.F.R. § 310.528 (2026) § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_528.md) - [21 C.F.R. § 310.529 (2026) § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_529.md) - [21 C.F.R. § 310.530 (2026) § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_530.md) - [21 C.F.R. § 310.531 (2026) § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_531.md) - [21 C.F.R. § 310.532 (2026) § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_532.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_518. 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