Label: NIGHTTIME SLEEP AID- diphenhydramine hcl liquid
- NDC Code(s): 72476-034-06, 72476-034-12
- Packager: Care One (Retail Business Services, LLC.)
- 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 17, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
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Warnings
Do not use
- with any other product containing diphenhydramine, even one used on the skin
- for children under 12 years of age
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®*
NIGHTTIME SLEEP AID
Diphenhydramine HCL, 50 mg
Alcohol 10%
Non-Habit-Forming
Not for treating cold or 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
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
- Package Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-034 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) ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-034-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2019 06/30/2025 2 NDC:72476-034-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2019 06/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2019 06/30/2025 Labeler - Care One (Retail Business Services, LLC.) (967989935)