Label: EZ NITE SLEEP- diphenhydramine hcl liquid
- NDC Code(s): 21130-014-06, 21130-014-12, 21130-014-24
- Packager: Safeway, Inc.
- Category: HUMAN OTC DRUG LABEL
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 4, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
-
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on 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
- breathing problem such as asthma emphysema or chronic bronchitis
- glaucoma
- heart disease
- 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 beverages and other drugs that cause drowsiness
- be careful when driving a motor vehicle or operating machinery
-
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=30mL 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 ZZZQUIL® active ingredient*
Nighttime Sleep Aid
Diphenhydramine HCI 50 mg
- Non-Habit Forming
- Not for treating cold or flu
- 10 % alcohol
- See warnings
Berry Flavor
fl oz (mL)
Failure to follow these warnings could results in serious consequenses.
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 Proctor & Gamble Company.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
- Package Label
-
INGREDIENTS AND APPEARANCE
EZ NITE SLEEP
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-014 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:21130-014-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 2 NDC:21130-014-24 2 in 1 PACKAGE, COMBINATION 06/30/2015 2 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:21130-014-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2015 Labeler - Safeway, Inc. (009137209)
