Label: SLEEP AID NIGHTTIME- diphenhydramine hcl liquid
- NDC Code(s): 49580-0314-2, 49580-0314-4, 49580-0314-6
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 26, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
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Warnings
Do not use
- in 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 emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
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
-
INGREDIENTS AND APPEARANCE
SLEEP AID NIGHTTIME
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0314 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) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0314-6 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2016 2 NDC:49580-0314-2 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2016 3 NDC:49580-0314-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 08/31/2016 Labeler - P & L Development, LLC (101896231)