446 - Nighttime Sleep Aid - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Poloxamer 407 Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-16

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50mg In each 30mL dose cup or 2 tablespoons

Use(s)

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

Directions

take only as recommended
use dosage cup or tablespoon

Age Dose

Adults & children

12 years & over: One Dose = 2 tablespoons (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 n for children under 12 years of age.
with any other product containing diphenhydramine, even one used on skin
with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Other Information

each 30 mL dose (2 tablespoons) contains: sodium 23 mg
dosage cup provided
store at room temperature
do not use if imprinted shrink band is missing or broken

Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM to 5PM

Active Ingredient(s)

Diphenhydramine HCl 50mg

In each 30mL dose cup or 2 tablespoons

Inactive Ingredients

citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup,

poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium

citrate, sodium saccharin

Principal Display Panel

Nighttime Sleep Aid

When Using This Product

do not use more than directed
avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Ask A Doctor Before Use If

heart disease
trouble urinating due to an enlarged prostate gland
glaucoma
a breathing problem such as asthma, emphysema or chronic bronchitis

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 Breastfeeding,

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.

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers or any other sleep aid

Structured Label Content

Use(s)

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

Purpose

Nighttime sleep-aid

Directions

take only as recommended
use dosage cup or tablespoon

Age Dose

Adults & children

12 years & over: One Dose = 2 tablespoons (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)

Do not use n for children under 12 years of age.
with any other product containing diphenhydramine, even one used on skin
with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Other Information (Other information)

each 30 mL dose (2 tablespoons) contains: sodium 23 mg
dosage cup provided
store at room temperature
do not use if imprinted shrink band is missing or broken

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM to 5PM

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 50mg

In each 30mL dose cup or 2 tablespoons

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup,

poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium

citrate, sodium saccharin

Principal Display Panel

Nighttime Sleep Aid

When Using This Product (When using this product)

do not use more than directed
avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Ask A Doctor Before Use If (Ask a doctor before use if)

heart disease
trouble urinating due to an enlarged prostate gland
glaucoma
a breathing problem such as asthma, emphysema or chronic bronchitis

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 Breastfeeding, (If pregnant or breastfeeding,)

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.

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

you are taking sedatives or tranquilizers or any other sleep aid

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "reduces time to fall asleep if you have difficulty falling asleep for relief of occasional sleeplessness", "Purpose": "Nighttime sleep-aid", "Directions": "take only as recommended use dosage cup or tablespoon Age Dose Adults & children 12 years & over: One Dose = 2 tablespoons (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 n for children under 12 years of age. with any other product containing diphenhydramine, even one used on skin with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products", "Other information": "each 30 mL dose (2 tablespoons) contains: sodium 23 mg dosage cup provided store at room temperature do not use if imprinted shrink band is missing or broken", "Questions/Comments": "Call 1-888-952-0050 Monday through Friday 9AM to 5PM", "Active ingredient(s)": "Diphenhydramine HCl 50mg In each 30mL dose cup or 2 tablespoons", "Inactive ingredients": "citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin", "Principal Display Panel": "Nighttime Sleep Aid", "When using this product": "do not use more than directed avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness", "Ask a doctor before use if": "heart disease trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as asthma, emphysema or chronic bronchitis", "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 breastfeeding,": "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.", "Ask a doctor or pharmacist before use if": "you are taking sedatives or tranquilizers or any other sleep aid"}

446 - Nighttime Sleep Aid