Antitussive
Monograph active ingredient
Diphenhydramine citrate
Oral antitussive 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 — 38 mg per dose
(iv) For products containing diphenhydramine citrate identified in § 341.14(a)(5). Adults and children 12 years of age and over: oral dosage is 38 milligrams every 4 hours, not to exceed 228 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 19 milligrams every 4 hours, not to exceed 114 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.21 CFR 341.74(d)(1)(iv)
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 a "cough suppressant" or an "antitussive (cough suppressant)."21 CFR 341.74(a)
Permitted indication
(2) "Temporarily" (select one of the following: "alleviates," "calms," "controls," "decreases," "quiets," "reduces," "relieves," or "suppresses") "cough" (select one of the following: "as may occur with," "associated with," or "occurring with") (select one of the following: "A cold," "the common cold," or "inhaled irritants").21 CFR 341.74(b)(2)
The warning the label must carry
(1) For oral and topical antitussives. "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 fever, rash, or persistent headache, consult a doctor."21 CFR 341.74(c)(1)
Diphenhydramine is an antihistamine the monograph also lists as an antitussive. A permitted oral antitussive not present in any FDA-listed lozenge or gum. No codified per-lozenge strength.
On the shelf
The monograph permits diphenhydramine citrate, 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 diphenhydramine citrate 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.