Guardian Nighttime Sleep-aid-633

Guardian Nighttime Sleep-aid-633
SPL v1
SPL
SPL Set ID 329d343f-2056-4870-930c-348917bfb2bc
Route
ORAL
Published
Effective Date 2024-01-11
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyoxyl 40 Stearate Saccharin Sodium Anhydrous Sodium Benzoate Sodium Citrate

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-11
Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Use(s)
  • for relief of occasional sleeplessness
  • helps you to fall asleep if you have difficulty falling asleep
Warnings

.

Directions
  • take only one dose per day (24 hours) - see Overdose warning
  • only use dosage cup that is included with this product for accurate dosing
  • mL = millilitere; Tbsp = teblespoons




Age 

Dose 
 adults & chlidren 12 year & over  one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
 childrens under 12 years  do not use


Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information
  • each 30 mL (2 Tbsp) contain: sodium 30 mg
  • store at room temperature
  • protect from light
Active Ingredient(s)

Diphenhydramine HCl 50 mg

Inactive Ingredients

citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.

Principal Display Panel

NDC 53041-633-58

*Compare to the active ingredient in ZZZQUIL® Nighttime Sleep-Aid



Nighttime Sleep-Aid

Warming Berry Flavor

Relieves:

Occasional Sleeplessness



6 FL OZ (177 ML)



When Using This Product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask Doctor If

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

Keep Out of Reach of Children

.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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
  • heart disease


Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers or any other sleep-aid.

Structured Label Content

Use(s) (USE(S))
  • for relief of occasional sleeplessness
  • helps you to fall asleep if you have difficulty falling asleep
Purpose (PURPOSE)

Nighttime sleep-aid

Warnings (WARNINGS)

.

Directions (DIRECTIONS)
  • take only one dose per day (24 hours) - see Overdose warning
  • only use dosage cup that is included with this product for accurate dosing
  • mL = millilitere; Tbsp = teblespoons




Age 

Dose 
 adults & chlidren 12 year & over  one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
 childrens under 12 years  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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Overdose Warning (OVERDOSE WARNING)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information (OTHER INFORMATION)
  • each 30 mL (2 Tbsp) contain: sodium 30 mg
  • store at room temperature
  • protect from light
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine HCl 50 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 53041-633-58

*Compare to the active ingredient in ZZZQUIL® Nighttime Sleep-Aid



Nighttime Sleep-Aid

Warming Berry Flavor

Relieves:

Occasional Sleeplessness



6 FL OZ (177 ML)



When Using This Product (WHEN USING THIS PRODUCT)
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

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
  • heart disease


Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

taking sedatives or tranquilizers or any other sleep-aid.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:41.406584 · Updated: 2026-03-14T23:02:23.126471