Label: BERKLEY AND JENSEN SLEEP AID- diphenhydramine hcl solution
- NDC Code(s): 68391-186-40
- Packager: BJWC
- 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 April 6, 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
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- for children under 12 years of age
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
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- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
Compare to the Active Ingredient in Vicks® ZzzQuil®
berkley jensen®
Compare to the Active Ingredient in Vicks® ZzzQuil®
berkley jensen®
SLEEP-AID
DIPHENHYDRAMINE HCl 50 mg PER 30 mL
NIGHTTIME SLEEP-AID
NON-HABIT FORMING
NOT FOR TREATING COLD OR FLU
10% ALCOHOL
NIGHTTIME SLEEP-AID
SLEEP-AID
DIPHENHYDRAMINE HCl 50 mg PER 30 mL
HELPS YOU FALL ASLEEP • NON-HABIT FORMING
100% MONEY-BACK GUARANTEE
BERRY FLAVOR
THREE 12 FL OZ (355mL) BOTTLES, TOTAL 36 FL OZ (2.25 pt) 1.06L
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INGREDIENTS AND APPEARANCE
BERKLEY AND JENSEN SLEEP AID
diphenhydramine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-186 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:68391-186-40 3 in 1 CARTON 07/23/2020 1 355 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 07/23/2020 Labeler - BJWC (159082692)