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Nyumbani / Dawa A–Z / Doxylamine

Doxylamine

helps to reduce difficulty in falling asleep.

Checked against the official label · Updated

Sold without prescription in some countries Oral Safety alerts on record

How to use Doxylamine

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Helps to reduce difficulty in falling asleep

How to take it and how often
  • Adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • Children under 12 years of age: do not use
While you are taking it

avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime

Talk to a doctor first if

a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland

Warnings

Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. …

Possible side effects

Sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Pregnancy and breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

How to store it

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number Keep out of reach of children.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-04-06.

Brands around the world

Products with Doxylamine as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Hyvee Nighttime Severe Cold And Flu SoftgelACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1 · Capsule, Liquid Filled · HyVee Inc
NDC 42507-888Label
Nighttime Cold And Flu Max SoftgelsACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1 · Capsule, Liquid Filled · Topco Associates, LLC
NDC 76162-913Label
Childrens Cough And Congestion, Childrens Cold And Cough Day, Night Day, NightKit · WALMART INC.
NDC 79903-414Label
Alka-seltzer Plus Cold NightASPIRIN 500 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1 · Tablet, Effervescent · Bayer HealthCare LLC.
NDC 0280-1545Label
Nighttime Cold And Flu Multi Symptom ReliefACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1 · Capsule, Liquid Filled · Shield Pharmaceuticals Corp
NDC 83059-0177Label

Nigeria (NAFDAC)

NAFDACZedex D B4-6297NAFDACVixa Night-Time Relief Caplet## (strength format) A4-100369

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 6945U.S. FDA Class III
7 Aug 2026 · Bionpharma Inc. · OngoingPresence of Foreign Tablets/Capsules
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); NiU.S. FDA Class II
14 Nov 2024 · LNK International, Inc. · TerminatedCGMP Deviations: Released product should have been rejected.
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807U.S. FDA Class II
3 May 2023 · Denison Pharmaceuticals, LLC · OngoingCGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 3U.S. FDA Class III
4 Aug 2022 · LNK International, Inc. · TerminatedLabeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Doxylamine

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Doxylamine

What is Doxylamine used for?

helps to reduce difficulty in falling asleep (From the official U.S. FDA label.)

How do I take Doxylamine?

Follow your prescription or the leaflet in your pack. The official label says: adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use…

Do I need a prescription for Doxylamine?

In many countries Doxylamine is sold without a prescription in some strengths. Rules differ by country, so ask a pharmacist.

What brands contain Doxylamine?

Doxylamine is sold under names such as Diclegis, Wal-som (doxylamine), Bonjesta, Unisom, Nocto, Zzzquil Ultra, Aldex An, Sleep Aid. Brand names differ between countries.

What are the side effects of Doxylamine?

The official label lists: sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. Tell your doctor about any side effect that bothers you or does not go away.

Can children take Doxylamine?

The label gives a separate dose by age: children 12 years. Check the pack or ask a pharmacist.

Can I take Doxylamine when pregnant or breastfeeding?

If pregnant or breast-feeding, ask a health professional before use. Ask your doctor or midwife first.

Can I drink alcohol with Doxylamine?

The official label says: Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a d…

How should I store Doxylamine?

EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

How can I check that my Doxylamine is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.