Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Sleep Aid Tablet
FDA Label NDC 11822-3000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Sleep Aid (NDC 11822-3000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Use
- helps to reduce difficulty in falling asleep
Do Not Use
in 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 (1-800-222-1222).
Directions
- 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
Other Information
- store at 68◦-77◦F (20◦-25◦C)
- retain in carton until time of use
- see carton end panel for lot number and expiration date
Inactive Ingredients
anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
FREE FROM | GLUTEN FREE
Compare to the active ingredient of Vicks® ZzzQuil® Ultra
SLEEP AID
DOXYLAMINE SUCCINATE TABLETS, 25 mg
nighttime sleep-aid
ACTUAL SIZE
helps to reduce difficulty in falling asleep
24 TABLETS
ONE TABLET PER DOSE
Sleep Aid-image (Image 01)
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