Sold without prescription in some countries Oral Safety alerts on record
How to use Doxylamine succinate
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.
Night Time Cold And Flu Relief Multi Symptom Multi SymptomACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1 · Capsule, Liquid Filled · Rite Aid Corporation
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 succinate
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts
Questions about Doxylamine succinate
What is Doxylamine succinate used for?
helps to reduce difficulty in falling asleep (From the official U.S. FDA label.)
How do I take Doxylamine succinate?
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 succinate?
In many countries Doxylamine succinate is sold without a prescription in some strengths. Rules differ by country, so ask a pharmacist.
What brands contain Doxylamine succinate?
Doxylamine succinate is sold under names such as Diclegis, Wal-som (doxylamine), Bonjesta, Unisom, Nocto, Zzzquil Ultra, Aldex An, Sleep Aid. Brand names differ between countries.
How can I check that my Doxylamine succinate 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.