Label: EZ NITE SLEEP- diphenhydramine hydrochloride solution
- NDC Code(s): 30142-549-30, 30142-549-40, 30142-549-50
- Packager: Kroger Company
- 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 February 22, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
- Warnings
- 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?
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INGREDIENTS AND APPEARANCE
EZ NITE SLEEP
diphenhydramine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-549 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 ALCOHOL (UNII: 3K9958V90M) 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) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color PURPLE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-549-30 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2019 2 NDC:30142-549-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2019 3 NDC:30142-549-50 2 in 1 PACKAGE 05/09/2019 3 355 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 05/09/2019 Labeler - Kroger Company (006999528)