FDA
Doxylamine Succinate
The FDA lists this product in 4 strengths and forms.
Indications
Use(s) helps to reduce difficulty in falling asleep
Warnings and precautions
Warnings Do not use in children under 12 years of age Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking any other drugs. When using this product avoid alcoholic beverages take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Pregnancy and breastfeeding
If pregnant or breastfeeding, ask a health professional before use.
Composition
- Active ingredients
- DOXYLAMINE SUCCINATE 25MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA040564.
At a glance
- Brand name
- Doxylamine Succinate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- LNK
- Status
- Over the counter
- FDA approval
- 27 Aug 2004
- Application
- ANDA040564-001