CalmCo Sleep Aid

CalmCo Sleep Aid is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HCL. It is labelled by CalmCo LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 73282-2527, application M010, label effective 20260626. It is one of 90 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIPHENHYDRAMINE HCL are most often described in connection with: relief occasional, sleeplessness reduces, time fall, difficulty falling. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep

Directions ■ do not take more than directed ■ chew thoroughly before swallowing Age Dose (chew) adults and children 12 years and over take 2 chewables at bedtime if needed children under 12 years do not use

Warnings ________ Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ in children under 12 years of age Ask a doctor before use if you have ■ have a breathing problem such as emphysema or chronic bronchitis ■ have glaucoma ■ have trouble urinating due to an enlarged prostate gland ■ are taking sedatives or tranquilizers When using this product ■ avoid alcohol beverages Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

FDA lists 90 drug label records with DIPHENHYDRAMINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is CalmCo Sleep Aid used for?
Uses ■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep

Who makes CalmCo Sleep Aid?
CalmCo LLC is the labeler of record for CalmCo Sleep Aid. 90 FDA label records share the active ingredient DIPHENHYDRAMINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does CalmCo Sleep Aid come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is CalmCo Sleep Aid prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPHENHYDRAMINE HCL?
Yes. 90 FDA drug label records list DIPHENHYDRAMINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has CalmCo Sleep Aid been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.