Doxylamine succinate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Doxylamine succinate is an antihistamine that is FDA approved for the treatment of allergic rhinitis, common cold, insomnia. Common adverse reactions include somnolence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Nighttime sleep-aid
Dosage
- Take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Doxylamine Succinate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxylamine Succinate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- Nighttime sleep-aid
Dosing
- 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
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Doxylamine Succinate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxylamine Succinate in pediatric patients.
Contraindications
There is limited information regarding Doxylamine succinate Contraindications in the drug label.
Warnings
Do not give
- To children under 12 years of age
Ask a doctor before use if you have
- A breathing problem such as asthma, emphysema or chronic bronchitis
- Glaucoma
- Trouble urinating due to an enlarged 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 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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Doxylamine Succinate in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Doxylamine Succinate in the drug label.
Drug Interactions
There is limited information regarding Doxylamine succinate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Doxylamine succinate in women who are pregnant.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxylamine Succinate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Doxylamine Succinate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Doxylamine Succinate with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Doxylamine Succinate with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Doxylamine Succinate with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Doxylamine Succinate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Doxylamine Succinate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Doxylamine Succinate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Doxylamine Succinate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Doxylamine Succinate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Doxylamine Succinate in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
There is limited information regarding Monitoring of Doxylamine Succinate in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Doxylamine Succinate in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Doxylamine Succinate in the drug label.
Pharmacology
Mechanism of Action
There is limited information regarding Doxylamine succinate Mechanism of Action in the drug label.
Structure
There is limited information regarding Doxylamine succinate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Doxylamine Succinate in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Doxylamine Succinate in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Doxylamine Succinate in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Doxylamine Succinate in the drug label.
How Supplied
There is limited information regarding Doxylamine succinate How Supplied in the drug label.
Storage
There is limited information regarding Doxylamine succinate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Doxylamine Succinate in the drug label.
Precautions with Alcohol
- Alcohol-Doxylamine Succinate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- 7 SELECT SLEEP AID
- Unisom
Look-Alike Drug Names
There is limited information regarding Doxylamine succinate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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