Label: SLEEP AID NIGHTTIME- diphenhydramine hcl liquid
- NDC Code(s): 55319-314-06, 55319-314-12
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Use
-
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
-
Directions
- take only one dose per day (24 hours) - see Overdose warning
- 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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN ZZZQUIL®*
eZe Nite Sleep Aid
NIGHTTIME SLEEP-AID
Diphenhydramine HCL 50 mg
Non Habit-Forming
Alcohol 10%
Not for treating Cold & Flu
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.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
- Product Label
-
INGREDIENTS AND APPEARANCE
SLEEP AID NIGHTTIME
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-314 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-314-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2017 07/31/2025 2 NDC:55319-314-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2017 07/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 07/31/2017 07/31/2025 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
