Other
Drug Facts
Nighttime Sleep-aid Liquid
FDA Label NDC 76281-522
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Nighttime Sleep-aid (NDC 76281-522). 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 other, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
(in each 30 mL dose cup or 2 tablespoons)
Diphenhydramine HCI 50 mg
Purpose
Nighttime sleep-aid
Uses
■ reduces time to fall asleep if you have difficulty falling asleep
■ for relief of occasional sleeplessness
Warnings
Do not use ■ 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 You Have
■ heart disease
■ trouble urinating due to enlarged prostrate gland
■ glaucoma
■ a breathing problem such as asthma, emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 One Dose = 2 tablespoons (30 mL) at bed
years & over time if needed or as directed by a doctor
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
Otc - Questions
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
Nighttime Sleep-Aid Label
NDC 76281-522-28
AP SAFE
*COMPARE TO the
active ingredient in ZzzQUIL™
NIGHTTIME SLEEP-AID
Nighttime
Sleep-Aid
Diphenhydramine HCI
Non-Habit Forming
Not for treating Cold or Flu
Warming Berry
Flavored Liquid
12 FL OZ (354 mL)
DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
Drug Facts
Active ingredient Purpose
(in each 30 mL dose cup or 2 tablespoons)
Diphenhydramine HCI 50 mg…………………………Nighttime sleep-aid
Uses
■ reduces time to fall asleep if you have difficulty falling asleep
■ for relief of occasional sleeplessness
Warnings
Do not use ■ 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 you have
■ heart disease
■ trouble urinating due to enlarged prostrate 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 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. ►
Drug Facts(continued)
Directions
■ take only as recommended
■ Use dosage cup or tablespoon
Age Dose
Adults & children 12 One Dose = 2 tablespoons (30 mL) at bed
years & over time if needed or as directed by a doctor
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? Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
*This product is not manufactured or distributed by Procter
& Gamble, owner of the registered trademark ZzzQuil™
Manufactured by: AptaPharma Inc.,
1533 Union Ave.,
Pennsauken, NJ 08110
AP-LR-10
Image Description (Nigtimesleepaid)
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