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Doxylamine

Doxylamine is an antihistamine used in over-the-counter products to help with trouble falling asleep and, in some liquid and capsule products, to relieve hay fever and other upper respiratory allergy symptoms.

Brand names Aldex ANNighttime Sleep AidUnisom SleepTabsUnisomNocto +11 more
Drug class Antihistamine
OTC Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 53 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 3, 2026
Doxylamine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Doxylamine is an older, sedating over-the-counter antihistamine and one of the most familiar drugstore sleep aids, on the market since about 1948 and available as a generic. By blocking histamine, it brings on drowsiness for trouble falling asleep and, in certain liquid and capsule products, relieves hay fever and upper respiratory allergy symptoms. Most people tolerate it well for occasional use, but the drowsiness can linger into the next morning, and dry mouth is common. Avoid alcohol, do not drive after taking it, and stop and see a doctor if sleeplessness lasts more than two weeks, since ongoing insomnia can signal an underlying illness.

Clinical pearls

  • Take the sleep-aid tablets about 30 minutes before bed, and only when you have time for a full night’s sleep.
  • NyQuil and many nighttime cold products already contain doxylamine, so do not stack them with a doxylamine sleep aid.
  • Glaucoma, emphysema, chronic bronchitis or trouble urinating from an enlarged prostate can be made worse, so check before using it.
  • Older adults are often steered toward other options, because it can cause confusion, unsteadiness and falls.
How you get itOver the counter
Comes asTablet, Oral solution, Capsule
Earliest FDA record1948
Companies listing it with the FDA54
FDA label last updatedDec 1, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Doxylamine, written from its FDA label.

What Doxylamine is used for

▾

Doxylamine is used for sleep and for allergy symptoms, depending on the product.

  • Sleep-aid tablets (such as Nighttime Sleep Aid and berkley and jensen sleep aid) help reduce difficulty in falling asleep.
  • Vicks NyQuil capsules, Vicks NyQuil ALLERGY and Kids ALLERGY liquids, Walgreens liquid and Sambrosa syrup temporarily relieve hay fever or other upper respiratory allergy symptoms.
  • Those symptoms are runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat.

Doxylamine dosage

▾

Doxylamine is taken by mouth, and the schedule depends on the product.

  • Sleep-aid tablets: one tablet about 30 minutes before bed, once daily or as directed by a doctor. Not for children under 12.
  • Vicks NyQuil capsules: taken every 4 hours, with a daily limit on the label. Do not use under age 4.
  • Vicks NyQuil ALLERGY, Kids ALLERGY and Walgreens liquids: use the dose cup, up to 4 doses a day. Age rules apply.
  • Sambrosa syrup: use the provided measuring spoon every 4 to 6 hours, with a daily limit. Children under 12 should consult a doctor.

Follow your product label and your prescriber or pharmacist.

Dosing details from the FDA-approved label

From the Doxylamine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults and children 12 years of age and over (tablet sleep aids, including Unisom SleepTabs and Vicks ZzzQuil)
    • Take one tablet 30 minutes before going to bed
    • Take once daily or as directed by a doctor
  • Children under 12 years of age (tablet sleep aids)
    • Do not use
  • Sambrosa syrup: adults and children 12 years of age and over
    • Oral dosage is 3 mL every 4 to 6 hours, or as directed by a doctor
    • A full spoon equals 3mL
    • Maximum: not to exceed 18 mL in 24 hours
    • always use the provided measurement spoon
  • Sambrosa syrup: children under 12 years of age
    • Consult a doctor
  • Liquid (Walgreens, Vicks NyQuil Kids ALLERGY, Vicks NyQuil ALLERGY): adults & children 12 yrs & over
    • 30 mL every 4 hrs
    • Maximum: do not exceed 4 doses per 24 hrs
    • only use the dose cup provided
  • Liquid: children 6 to under 12 yrs
    • 15 mL every 4 hrs
    • Maximum: do not exceed 4 doses per 24 hrs
    • only use the dose cup provided
  • Liquid: children 4 to under 6 yrs
    • Ask a doctor
  • Liquid: children under 4 yrs
    • Do not use
  • Vicks NyQuil LiquiCaps: adults & children 12 yrs & over
    • 2 LiquiCaps every 4 hrs
    • Maximum: do not exceed 4 doses (8 LiquiCaps) per 24 hrs
  • Vicks NyQuil LiquiCaps: children 4 to under 12 yrs
    • Ask a doctor
    • children under 4 yrs: do not use
Read the label’s full dosing text

Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Read the full Dosage and Administration section on DailyMed →

Doxylamine warnings and precautions

▾
  • Avoid alcohol while using doxylamine.
  • Do not drive or operate machinery.
  • For sleep, take only at bedtime.
  • Stop and ask a doctor if sleeplessness lasts more than two weeks. Insomnia can signal a serious underlying illness.
  • Keep out of reach of children.

Doxylamine interactions

▾

Check with a doctor or pharmacist before combining doxylamine with these.

  • Sedatives, sleep aids or tranquilizers.
  • Other antihistamines.
  • Any other drugs.
  • Alcohol: avoid it.
  • Other doxylamine products, in children under 12.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Doxylamine

▾
  • Breathing problems such as emphysema or chronic bronchitis.
  • Trouble urinating due to an enlarged prostate gland.
  • Glaucoma.
  • Pregnancy or breast-feeding: ask a health professional first.
  • Children: sleep-aid tablets are not for those under 12. Allergy products have age limits.

Doxylamine overdose

▾

In case of overdose, get medical help or call Poison Control at 1-800-222-1222 right away. Quick attention is critical for adults and children, even if you don’t notice symptoms.

How to store Doxylamine

▾

store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Doxylamine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Doxylamine — the kind of thing our pharmacy team would talk through with you at the counter.

What is doxylamine used for?

▾
It depends on the product. Sleep-aid tablets help you fall asleep more easily. Some NyQuil and other liquid or syrup products relieve hay fever and upper respiratory allergy symptoms like sneezing and runny nose.

How do I take the sleep-aid tablets?

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Adults and children 12 and over take one tablet about 30 minutes before bed, once daily or as your doctor directs. Take it only at bedtime. These tablets are not for children under 12.

Can I have a drink with it?

▾
No. The label says to avoid alcohol while using doxylamine. Also don’t drive or run machinery.

Should I check with someone before using it?

▾
Yes, if you have emphysema or chronic bronchitis, glaucoma, or trouble urinating from an enlarged prostate. Also check if you take sedatives, other sleep aids, or other antihistamines. If you’re pregnant or breast-feeding, ask a health professional first.

How long can I use it for sleep?

▾
If sleeplessness lasts more than two weeks, stop and talk to a doctor. Ongoing insomnia can be a sign of a serious underlying illness.

What if someone takes too much?

▾
Call Poison Control at 1-800-222-1222 or get medical help right away. Do this even if there are no symptoms, for adults and children alike.

Is Doxylamine available over the counter?

▾
Yes. The Doxylamine products listed with the FDA are sold over the counter, without a prescription (the tablet, oral solution and capsule forms). Follow the package directions. Your pharmacist can tell you which product is right for you.

When was Doxylamine first available?

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The earliest FDA record we hold for Doxylamine is from 1948: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Doxylamine was first used.

Who makes Doxylamine?

▾
54 companies list Doxylamine products in the FDA's NDC Directory, including The Procter & Gamble Manufacturing Company, Kroger Company, Rite Aid Corporation. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Doxylamine on HelloPharmacist

Detailed data & references for Doxylamine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Doxylamine forms and strengths (how it comes)

Doxylamine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Good Sense Sleep Aid Ultra Nighttime Sleep-Aid Nighttime Sleep Aid Nocto Sleep Aid Sleep-Aid Sleep Aid Topcare Sleep Aid Ultra Sleep Aid Unisom SleepTabs Up And Up Nighttime Sleep Aid
How this form is used
What it may be used for
  • Nighttime Sleep Aid, Night Time Sleep Aid, Nighttime Sleep-Aid, berkley and jensen sleep aid, Good Sense Sleep Aid Ultra and 24-7 Life by 7-Eleven tablets help reduce difficulty in falling asleep.
Important instructions
  • These tablet products: adults and children 12 and over take one tablet 30 minutes before bed, once daily or as directed by a doctor.
  • These tablet products: do not use in children under 12.
Available strengths 1 strength
116 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Vicks NyQuil ALLERGY
How this form is used
What it may be used for
  • Sambrosa, Vicks NyQuil ALLERGY, Vicks NyQuil Kids ALLERGY and Walgreens liquids temporarily relieve hay fever and upper respiratory allergy symptoms.
Important instructions
  • Sambrosa: use the provided measuring spoon. Children under 12 should consult a doctor.
  • Vicks NyQuil ALLERGY, Vicks NyQuil Kids ALLERGY and Walgreens: use the dose cup provided and do not exceed 4 doses in 24 hours.
  • Vicks NyQuil ALLERGY, Vicks NyQuil Kids ALLERGY and Walgreens: do not use under age 4. Ask a doctor for ages 4 to under 6.
Available strengths 3 strengths
9 FDA-listed product records ⓘ

Capsule

By mouth
Brands Vicks NyQuil
How this form is used
What it may be used for
  • Vicks NyQuil capsules temporarily relieve runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat from hay fever or other upper respiratory allergies.
Important instructions
  • Vicks NyQuil: adults and children 12 and over take 2 LiquiCaps every 4 hours, with no more than 4 doses (8 LiquiCaps) in 24 hours.
  • Vicks NyQuil: ask a doctor for children 4 to under 12. Do not use under age 4.
Available strengths 1 strength
3 FDA-listed product records ⓘ

Doxylamine on the U.S. market: products, makers and brands

How Doxylamine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

54 companies list 139 Doxylamine product records with the FDA, mostly as tablet, oral solution, capsule; the earliest marketing or approval year on record is 1948. Brand names on the directory include Aldex AN, Nighttime Sleep Aid, Unisom SleepTabs and 13 more; the rest are generics.

3
Dose forms ⓘ
54
Labelers (makers, repackagers, distributors)
33
Brand names
139
FDA-listed product records ⓘ
1948
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

The Procter & Gamble Manufacturing Company6%
Kroger Company6%
Rite Aid Corporation5%
CVS Pharmacy5%
L.N.K. International, Inc.5%
Walgreen Company5%
Other makers69%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Doxylamine is used (Medicaid data)

A general measure of how commonly Doxylamine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Doxylamine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

13,518
Medicaid prescriptions filled (Q1–Q4 2025)
$149,467 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Doxylamine prescribed? Of the 1,601 medications we measure, Doxylamine ranks #880 by Medicaid prescriptions — more than 45% of them.

Where Doxylamine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Doxylamine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

doxylamine succinate 25 MG Oral Tablet

13,518 Medicaid prescriptions (Q1–Q4 2025) 100% of Doxylamine prescriptions shown $149,467 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 5 of 108 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1101446

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Doxylamine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 108 listed Doxylamine NDCs with Medicaid activity.

Compare Doxylamine products

A representative set of FDA-listed product records for Doxylamine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 139 of 139 products — FDA National Drug Code Directory. See every product, package size and price: browse all 139 Doxylamine NDCs →

Doxylamine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Doxylamine recalls since July 2021.

✅No Doxylamine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Doxylamine RxCUI 3642 4 dose forms · 6 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 794633 No current FDA listing
    Clinical drug / strength (SCD) succinate 5 MG RxCUI 1101439
  2. Dose form (SCDF) Oral Capsule RxCUI 371967 In current FDA listings
    Clinical drug / strength (SCD) succinate 6.25 MG RxCUI 2745969
  3. Dose form (SCDF) Oral Solution RxCUI 706842 In current FDA listings
    Clinical drug / strength (SCD) succinate 0.417 MG/ML RxCUI 2715412 succinate 1 MG/ML RxCUI 1101457 succinate 3.26 MG/ML RxCUI 2390292
  4. Dose form (SCDF) Oral Tablet RxCUI 371968 In current FDA listings
    Clinical drug / strength (SCD) succinate 25 MG RxCUI 1101446

Look up RxCUI 3642 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Doxylamine brand names

Doxylamine is sold under 16 brand names in the FDA directory — Aldex AN, Nighttime Sleep Aid, Unisom SleepTabs, Unisom and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Aldex AN Nighttime Sleep Aid Unisom SleepTabs Unisom Nocto Zzzquil Ultra sleep aid TopCare Sleep Aid Sleep-Aid Nocto Sleep Aid good sense sleep aid ultra Vicks NyQuil ALLERGY Nighttime Sleep-Aid ultra sleep aid up and up nighttime sleep aid sleep aid ultra

Who makes Doxylamine: manufacturers and labelers

40 companies list Doxylamine products with the FDA. By number of product records, the largest are The Procter & Gamble Manufacturing Company, Kroger Company, Rite Aid Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

The Procter & Gamble Manufacturing Company 8 Kroger Company 7 Rite Aid Corporation 6 CVS Pharmacy 6 L.N.K. International, Inc. 6 Walgreen Company 6 Topco Associates LLC 5 L. Perrigo Company 5 Cardinal Health 110, LLC. dba Leader 5 Meijer Distribution Inc 4 Chattem, Inc. 4 Costco Wholesale Corporation 4 Belmora LLC 4 H E B 4 Yyba Corp 3 Lil' Drug Store Products, Inc. 3 Wal-Mart Stores Inc 3 Strategic Sourcing Services LLC 3 Amazon.com Services LLC 3 Army And Air Force Exchange Service 3 Better Living Brands, LLC 3 Target Corporation 2 American Sales Company 2 Strategic Sourcing Services, LLC (Health Mart) 2

…and 16 more on the FDA NDC directory.

Doxylamine drug class (RxNorm)

Doxylamine belongs to the Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Aminoalkyl ethers
How it works Histamine Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Doxylamine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 1, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Doxylamine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Doxylamine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
53
NDC products indexed
139
Distinct labelers/manufacturers represented
54
Linked representative label ⓘ
Lil' Drug Store Products, Inc.
Linked label effective
Dec 1, 2025
Composite sections available
8
Linked SPL Set ID
0f8c7219-7b40-27c6-e063-6294a90a27d9
Linked SPL Document ID
44e705b6-fd79-dd85-e063-6294a90a7d6f
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lil' Drug Store Products, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →