Active Ingredient(S)
Diphenhydramine HCl 50mg
Nighttime Sleep Aid Liquid
FDA Label NDC 69168-446
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 69168-446). 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)
- reduces time to fall asleep if you have difficulty falling asleep
- for relief of occasional sleeplessness
Do Not Use
- Do not use n for children under 12 years of age.
- with any other product containing diphenhydramine, even one used on skin
- with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Ask A Doctor Before Use If
- heart disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as asthma, emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If
you are taking sedatives or tranquilizers or any other sleep aid
When Using This Product
- do not use more than directed
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of serious underlying medical illness.
If Pregnant Or Breastfeeding,
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.
Directions
- take only as recommended
- use dosage cup or tablespoon
Age Dose
Adults & children
12 years & over: One Dose = 2 tablespoons (30 mL) at bed time if needed or as directed by a doctor
Children under 12 yrs: Do not use
Other Information
- each 30 mL dose (2 tablespoons) contains: sodium 23 mg
- dosage cup provided
- store at room temperature
Inactive Ingredients
citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup,
poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium
citrate, sodium saccharin
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM to 5PM
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Sleep Aid Liquid
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