Active Ingredient(S)
Doxylamine succinate 25 mg
Nighttime Sleep Aid Tablet
FDA Label NDC 69168-439
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Nighttime Sleep Aid (NDC 69168-439). 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(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, 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(S)
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 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.
Directions
Adults and children 12 years 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
- DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- store at controlled room temperature 20°– 25°C (68°– 77°F)
- use by expiration date on package
Inactive Ingredients
dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate
Questions
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Nighttime Sleep Aid (439 Nighttime Sleep Aid 1)
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