Other
Monograph active ingredient
Guaifenesin
Expectorant under FDA monograph M012. Its permitted strength and indication are set by 21 CFR 341 and quoted here from the regulation.
What the monograph permits
Every figure below is the regulation's own sentence, quoted rather than summarised, with the paragraph it comes from.
Oral, any dosage form — 200 to 400 mg per dose
Adults and children 12 years of age and over: oral dosage is 200 to 400 milligrams every 4 hours not to exceed 2,400 milligrams in 24 hours. Children 6 to under 12 years of age: oral dosage is 100 to 200 milligrams every 4 hours not to exceed 1,200 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 50 to 100 milligrams every 4 hours not to exceed 600 milligrams in 24 hours. Children under 2 years of age: consult a doctor.21 CFR 341.78(d)
21 CFR 341, 2025 annual edition, retrieved from govinfo on 9 September 2026. How the monograph system works.
What the label may say
The monograph fixes both what the product must call itself and the indication wording it may use. These are the permitted phrases, verbatim; a product may not claim more than this.
Statement of identity
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an "expectorant."21 CFR 341.78(a)
Permitted indication
"Helps loosen phlegm (mucus) and thin bronchial secretions to" (select one or more of the following: "rid the bronchial passageways of bothersome mucus," "drain bronchial tubes," and "make coughs more productive").21 CFR 341.78(b)
The warning the label must carry
(1) "A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor."21 CFR 341.78(c)(1)
Guaifenesin is the only expectorant active in the monograph. It is overwhelmingly a syrup or a tablet rather than a lozenge, and the monograph sets an oral dose rather than a per-lozenge strength.
On the shelf
The monograph permits guaifenesin, but no lozenge, pastille, troche or gum in the current FDA listing contains it . A permitted ingredient is not the same as an ingredient on a shelf, and this is one that is on the books without being in the box. Not currently listed
This page reports what the FDA monograph permits, not what you should take. It is not medical advice, and it makes no claim that guaifenesin is effective for any condition. Always follow the product label, and ask a pharmacist or a doctor.
Lozenges.com is a reference publication built from FDA product listings and drug labels. It is not medical advice, diagnosis or treatment, it does not recommend any product for any condition, and it is not a substitute for a pharmacist or a doctor.