bjwc sleep-aid drug facts

bjwc sleep-aid drug facts
SPL v3
SPL
SPL Set ID e31917a1-e72d-4f71-893f-43046169a32d
Route
oral
Published
Effective Date 2024-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (50 mg)
Inactive Ingredients
alcohol anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 high fructose corn syrup poloxamer 407 propylene glycol water saccharin sodium sodium benzoate sodium citrate, unspecified form

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2020-07-23

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg


Medication Information

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

Nighttime sleep-aid

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

Description

Diphenhydramine HCl 50 mg

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-800-BJS-CLUB

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).

Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

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
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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

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

Nighttime sleep-aid

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

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-800-BJS-CLUB

When Using This Product (When using this product)
  • avoid alcoholic beverages
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (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
Package/label Principal Display Panel (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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