Heb Nighttime Sleep-aid Drug Facts

Heb Nighttime Sleep-aid Drug Facts
SPL v6
SPL
SPL Set ID d5189048-5eed-4ec4-8c4a-4a167728c4e7
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 2013-10-30 Until 2024-06-30

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

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

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

1-800-719-9260

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

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 an enlargement of the prostate gland
Package/label Principal Display Panel

Compare to Vicks® ZzzQuil® active ingredient

H-E-B®

Nighttime Sleep-Aid

Diphenhydramine HCl 50 mg per 30 mL

Helps You Fall Asleep

ALCOHOL 10%

• Not for Treating Colds or Flu

• Non-Habit Forming

• Berry Flavor

12 FL OZ (355 mL)

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

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?

1-800-719-9260

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

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 an enlargement of the prostate gland
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to Vicks® ZzzQuil® active ingredient

H-E-B®

Nighttime Sleep-Aid

Diphenhydramine HCl 50 mg per 30 mL

Helps You Fall Asleep

ALCOHOL 10%

• Not for Treating Colds or Flu

• Non-Habit Forming

• Berry Flavor

12 FL OZ (355 mL)

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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