Active Ingredient (In Each 30 Ml)
Diphenhydramine HCl 50 mg
Nighttime Sleep Aid Liquid
FDA Label NDC 41520-034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Care One (american Sales Company) for the product Nighttime Sleep Aid (NDC 41520-034). 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 30 ml), purpose, uses, 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
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Do Not Use
- with any other product containing diphenhydramine, even one used on the skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids
Ask A Doctor Before Use If You Have
- heart disease
- glaucoma
- breathing problem such as asthma,emphysema, or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers or any other sleep-aid.
When Using This Product
- drowsiness will occur
- avoid alcoholic drinks and other drugs that cause drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only one dose per day (24 hours) - (see overdose warning)
- mL=milliliter
- measure only with dosing cup provided.Do not use any other dosing device
- keep dosing cup with product
- adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
- children under 12 years do not use
Other Information
- each 30 mL contains: sodium 23 mg
- store at 20-25°C (68-77°F)
- do not refrigerate
- protect from light
Inactive Ingredients
citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate
Questions Or Comments?
Call 1-877-753-3935 Monday-friday 9AM-5PM EST
Principal Display Panel
Compare to the Active Ingredient in ZZZQUIL®*
NIGHTTIME SLEEP AID
Diphenhydramine HCI 50 mg
Alcohol 10%
Non-Habit-Forming
Not for treating cold or flu
Berry Flavor
FL OZ (mL)
Failure to follow these warnings could result in serious consequences
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.
DISTRIBUTED BY
FOODHOLD USA LLC
LANDOVER, MD 20785
1-877-846-9949
Package Label
CAREONE Nighttime Sleep Aid
* Please review the disclaimer below.
