What are the rules for bilingual and translated drug labels in the US?

Required label statements must be in English, and if a label uses another language at all, every required statement has to appear in that language too. That's 21 CFR 201.15(c). The one carve-out: products distributed only in Puerto Rico or a US territory whose main language isn't English may use that language instead of English.

This page is general information, not legal or regulatory advice.

What the rule says

• English first. Every word, statement and piece of information the law requires on the label or labeling must appear in English (21 CFR 201.15(c)(1)).
• All or nothing for a second language. If the label contains any representation in a foreign language, all required statements must appear in that language as well (21 CFR 201.15(c)(2)). The same applies to other labeling (21 CFR 201.15(c)(3)). When that second language is Spanish, if any Spanish appears on the label, all the required statements, including the full Drug Facts content, have to appear in Spanish as well.
• Spanish-only labels are allowed only for products distributed solely in Puerto Rico or a territory where Spanish is the predominant language (21 CFR 201.15(c)(1)). For prescription drugs labeled that way, 21 CFR 201.16 fixes the Spanish for Rx only: it must be Solamente Rx.
• No space excuse. A firm can't claim a label is too small for required statements if the space went to foreign-language text (21 CFR 201.15(b)(3)).

So in our reading, a half-translated panel, with the uses in two languages and the warnings in one, doesn't appear to meet the rule.

Where wrong words come in

A second language doubles the text that has to be right, and a translator or a translation tool can produce a correctly spelled wrong word in either language. Spellcheck won't flag it in English or in the other language, because the word is real.

Spanish Drug Facts: same failure, second language

A Spanish translation can carry a correctly spelled wrong word just as English can, and spellcheck in Spanish won't flag it either. Have a fluent reader check the Spanish warnings, directions and stop-use lines for meaning, and make sure they say the same thing as the English.

What helps in practice (good habits, not legal requirements):

• Read each language for meaning, by someone fluent in it, on the high-stakes lines: warnings, directions and stop-use.
• Check that the two versions say the same thing, not just that both are present.
• Fix the source and every translation when you correct a wording error, so the fix doesn't land in one language only.

See how to proofread label sections for meaning and real English-language examples on the case index.

Sources

• eCFR: 21 CFR 201.15
• eCFR: 21 CFR 201.16

Last reviewed: October 14, 2026

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Do US drug labels have to be in English?

Yes. Required statements must appear in English, except for products distributed only in Puerto Rico or a US territory whose main language isn't English.

Can a US drug label be bilingual?

Yes, but if the label uses another language at all, every required statement must appear in that language too.

Can translation introduce wrong words on a label?

Yes. A correctly spelled wrong word can appear in either language, and spellcheck won't flag it because the word is real.

If an OTC label has any Spanish, does all of Drug Facts have to be in Spanish too?

Yes. Under 21 CFR 201.15(c)(2), if a label contains any foreign-language representation, all required statements must appear in that language too, so in our reading a partly translated Drug Facts panel doesn't appear to meet the rule.