FDA
Doxylamine Succinate
The FDA lists this product in 4 strengths and forms.
Indications
Use
- helps to reduce difficulty in falling asleep
Warnings and precautions
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
- a sedative 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. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Pregnancy and breastfeeding
If pregnant or breast-feeding, 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.
- DOXYLAMINE SUCCINATE 25MG · TabletANDA088603-001 · Discontinued
- DOXYLAMINE SUCCINATE 25MG · TabletANDA040564-001 · Over the counter
- DOXYLAMINE SUCCINATE 25MG · TabletThis page
At a glance
- Brand name
- Doxylamine Succinate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Perrigo
- Status
- Over the counter
- FDA approval
- 18 Sept 1996
- Application
- ANDA040167-001