Doxylamine succinate

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Doxylamine succinate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

This image is provided by the National Library of Medicine.

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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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

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This image of the FDA label is provided by the National Library of Medicine.
Sleep Aid tablets.jpg
This image of the FDA label is provided by the National Library of Medicine.

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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