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.
🧬 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 →
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.
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?
▾
How do I take the sleep-aid tablets?
▾
Can I have a drink with it?
▾
Should I check with someone before using it?
▾
How long can I use it for sleep?
▾
What if someone takes too much?
▾
Is Doxylamine available over the counter?
▾
When was Doxylamine first available?
▾
Who makes Doxylamine?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Doxylamine on HelloPharmacist
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
How this form is used
- 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.
- 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.
Oral solution
How this form is used
- Sambrosa, Vicks NyQuil ALLERGY, Vicks NyQuil Kids ALLERGY and Walgreens liquids temporarily relieve hay fever and upper respiratory allergy symptoms.
- 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.
Capsule
How this form is used
- 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.
- 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.
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.
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.
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.
How commonly is Doxylamine prescribed? Of the 1,601 medications we measure, Doxylamine ranks #880 by Medicaid prescriptions — more than 45% of them.
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
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 6.25 mg | — | Catalent Ontario Limited × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 6.25 mg | Oral | The Procter & Gamble Manufacturing Company | OTC MONOGRAPH DRUG | View NDC → |
| 💊Oral solution | ||||
| 25 kg/25 kg | — | Hy-gro Chemicals Pharmtek Private Limited | BULK INGREDIENT | View NDC → |
| 9.78 mg/3 mL | Oral | Lelypharma bv | OTC MONOGRAPH FINAL | View NDC → |
| 9.78 mg/3 mL | Oral | Sambrosa Care, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 9.78 mg/3 mL | Oral | Sambrosa Care, Inc. | OTC MONOGRAPH FINAL | View NDC → |
| 6.25 mg/15 mL | Oral | The Procter & Gamble Manufacturing Company × 4 listings | OTC MONOGRAPH DRUG | View NDC → |
| 6.25 mg/15 mL | Oral | Walgreens Co. | OTC MONOGRAPH DRUG | View NDC → |
| 💊Tablet | ||||
| 25 mg | Oral | Advanced Rx LLC | ANDA | View NDC → |
| 25 mg | Oral | Amazon.com Services LLC × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | American Sales Company × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Amerisource Bergen × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Army And Air Force Exchange Service × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | Belmora LLC × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | Better Living Brands, LLC × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | Big Lots Stores, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Bjwc | ANDA | View NDC → |
| 25 mg | Oral | Cardinal Health | ANDA | View NDC → |
| 25 mg | Oral | Cardinal Health 110, LLC. DBA Leader × 5 listings | ANDA | View NDC → |
| 25 mg | Oral | Chattem, Inc. × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | Costco Wholesale Corporation × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | Cvs Pharmacy × 6 listings | ANDA | View NDC → |
| 25 mg | Oral | Cvs Woonsocket Prescription Center, Incorporated | ANDA | View NDC → |
| 25 mg | Oral | Dolgencorp Inc × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Grocery Outlet | ANDA | View NDC → |
| 25 mg | Oral | Harris Teeter, LLC | ANDA | View NDC → |
| 25 mg | Oral | H E B × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | HyVee Inc | ANDA | View NDC → |
| 25 mg | Oral | Kroger Company × 7 listings | ANDA | View NDC → |
| 25 mg | Oral | L.N.K. International, Inc. × 6 listings | ANDA | View NDC → |
| 25 mg | Oral | L. Perrigo Company × 5 listings | ANDA | View NDC → |
| 25 mg | Oral | Lil' Drug Store Products, Inc. × 3 listings | OTC MONOGRAPH DRUG | View NDC → |
| 25 mg | — | L Perrigo Company | DRUG FOR FURTHER PROCESSING | View NDC → |
| 25 mg | Oral | Meijer, Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Meijer Distribution Inc × 4 listings | ANDA | View NDC → |
| 25 mg | Oral | Publix Super Markets Inc | ANDA | View NDC → |
| 25 mg | Oral | Rite Aid Corporation × 6 listings | ANDA | View NDC → |
| 25 mg | Oral | Strategic Sourcing Services, LLC (Health Mart) × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Strategic Sourcing Services, LLC (Sunmark) | ANDA | View NDC → |
| 25 mg | Oral | Strategic Sourcing Services LLC × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | Supervalu Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Target Corporation × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | The Procter & Gamble Manufacturing Company × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | Topco Associates LLC × 5 listings | ANDA | View NDC → |
| 25 mg | Oral | United Natural Foods, Inc. dba UNFI | ANDA | View NDC → |
| 25 mg | Oral | Wal-Mart Stores Inc × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | Walgreen Company × 6 listings | ANDA | View NDC → |
| 25 mg | Oral | Yyba Corp × 3 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Cutyx Research LLP | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Cutyx Research LLP | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Honour Lab Limited | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Hy-gro Chemicals Pharmtek Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Malladi Drugs & Pharmaceuticals Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America dba PCCA | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | R.L.Fine Chem Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Shenzhen Oriental Pharmaceutical Co. Ltd | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Sigma-Aldrich Ireland Ltd. | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Union Quimico Farmaceutica SA (UQUIFA)-Sant Celoni | BULK INGREDIENT | View NDC → |
Showing 139 of 139 products — FDA National Drug Code Directory. See every product, package size and price: browse all 139 Doxylamine NDCs →
Doxylamine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Doxylamine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Doxylamine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Doxylamine FDA approval history
How Doxylamine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
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 2021Source: 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.
RxCUI 3642 4 dose forms · 6 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 794633No current FDA listingClinical drug / strength (SCD) succinate 5 MGRxCUI 1101439 -
Dose form (SCDF) Oral Capsule RxCUI 371967In current FDA listingsClinical drug / strength (SCD) succinate 6.25 MGRxCUI 2745969 -
Dose form (SCDF) Oral Solution RxCUI 706842In current FDA listingsClinical drug / strength (SCD) succinate 0.417 MG/MLRxCUI 2715412succinate 1 MG/MLRxCUI 1101457succinate 3.26 MG/MLRxCUI 2390292 -
Dose form (SCDF) Oral Tablet RxCUI 371968In current FDA listingsClinical drug / strength (SCD) succinate 25 MGRxCUI 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 supply and shortage status
Whether Doxylamine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
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.
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.
…and 16 more on the FDA NDC directory.
Doxylamine drug class (RxNorm)
Doxylamine belongs to the Antihistamine class.
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.
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 →