FDA Label for Sleep Aid Nighttime
View Indications, Usage & Precautions
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Sleep Aid Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 30 Ml)
Diphenhydramine HCl 50 mg
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
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on the skin
Ask A Doctor Before Use If You Have
- a breathing problem such as asthma or emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
avoid alcoholic beverages.
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 (1-800-222-1222) right away.
Directions
- take only one dose per day (24 hours)
- mL=milliliter
- keep dosing cup with product
- measure only with dosing cup provided. Do not use any other dosing device.
- 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, sodium citrate
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in ZZZQuil®*
ez Nite
Sleep Aid
diphenhydramine HCI 50 mg
nighttime sleep-aid
- non habit-forming
- not for treating cold or flu
- alcohol 10%
berry flavor
fl oz (mL)
Failure to follow these warnings could result in serious consequences.
*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQuil® is a registered trademark of The Procter & Gamble Company
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
Package Label
READYinCASE Ez Nite Sleep Aid Berry Flavor
* Please review the disclaimer below.