BERKLEY AND JENSEN SLEEP AID- diphenhydramine hcl solution

berkley and jensen sleep aid by

Drug Labeling and Warnings

berkley and jensen sleep aid by is a Otc medication manufactured, distributed, or labeled by BJWC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• for 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
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• take only one dose per day (24 hours)
• only use the dose cup provided

• adults & children 12 yrs & over:

  30 mL at bed time if needed or as directed by a doctor

• children under 12 yrs:

  do not use

Other information

• each 30 mL contains: sodium 20 mg
• store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

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

INGREDIENTS AND APPEARANCE

BERKLEY AND JENSEN SLEEP AID 
diphenhydramine hcl solution

Product 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 Drug	M010	07/23/2020

Labeler - BJWC (159082692)