Nighttime Sleep-aid

Nighttime Sleep-aid
SPL v3
SPL
SPL Set ID ed0ba7aa-e794-43da-b576-6b9945bf7477
Route
ORAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-01

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses

■ reduces time to fall asleep if you have difficulty falling asleep

■ for relief of occasional sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers or any other sleep aid

Section 53413-1

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not use ■ 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

Directions

■ take only as recommended

■ Use dosage cup or tablespoon

       Age                                     Dose

Adults & children 12          One Dose = 2 tablespoons (30 mL) at bed

years & over                    time if needed or as directed by a doctor

Active Ingredient

(in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCI 50 mg

Other Information

■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg

■ dosage cup provided

■ store at room temperature

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

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

Nighttime Sleep Aid Label

NDC 76281-522-28

AP SAFE

*COMPARE TO the

active ingredient in ZzzQUIL™

NIGHTTIME SLEEP-AID

Nighttime

Sleep-Aid

Diphenhydramine HCI

Non-Habit Forming

Not for treating Cold or Flu

Warming Berry

Flavored Liquid

12 FL OZ (354 mL)

DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

Drug Facts

Active ingredient                                                           Purpose

(in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCI 50 mg…………………………Nighttime sleep-aid

Uses

■ reduces time to fall asleep if you have difficulty falling asleep

■ for relief of occasional sleeplessness

Warnings

Do not use ■ 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

Ask a doctor before use if you have

■ heart disease

■ trouble urinating due to enlarged prostrate gland

■ glaucoma

■ a breathing problem such as asthma, emphysema or chronic

bronchitis

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers or any other 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

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. ►

Drug Facts (continued)

Directions

■ take only as recommended

■ Use dosage cup or tablespoon

        Age                                         Dose

Adults & children 12           One Dose = 2 tablespoons (30 mL) at bed

years & over                     time if needed or as directed by a doctor

Other information

■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg

■ dosage cup provided

■ store at room temperature

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

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

*This product is not manufactured or distributed by Procter

& Gamble, owner of the registered trademark ZzzQuil™

Manufactured by: AptaPharma Inc.,

1533 Union Ave.,

Pennsauken, NJ 08110

AP-LR-10

6 OZ

4 OZ

res

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.

Ask A Doctor Before Use If You Have

■ heart disease

■ trouble urinating due to enlarged prostrate gland

■ glaucoma

■ a breathing problem such as asthma, emphysema or chronic bronchitis


Structured Label Content

Uses

■ reduces time to fall asleep if you have difficulty falling asleep

■ for relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers or any other sleep aid

Section 53413-1 (53413-1)

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Warnings

Do not use ■ 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

Directions

■ take only as recommended

■ Use dosage cup or tablespoon

       Age                                     Dose

Adults & children 12          One Dose = 2 tablespoons (30 mL) at bed

years & over                    time if needed or as directed by a doctor

Active Ingredient (Active ingredient)

(in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCI 50 mg

Other Information (Other information)

■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg

■ dosage cup provided

■ store at room temperature

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

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

Nighttime Sleep Aid Label (Nighttime Sleep-Aid Label)

NDC 76281-522-28

AP SAFE

*COMPARE TO the

active ingredient in ZzzQUIL™

NIGHTTIME SLEEP-AID

Nighttime

Sleep-Aid

Diphenhydramine HCI

Non-Habit Forming

Not for treating Cold or Flu

Warming Berry

Flavored Liquid

12 FL OZ (354 mL)

DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

Drug Facts

Active ingredient                                                           Purpose

(in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCI 50 mg…………………………Nighttime sleep-aid

Uses

■ reduces time to fall asleep if you have difficulty falling asleep

■ for relief of occasional sleeplessness

Warnings

Do not use ■ 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

Ask a doctor before use if you have

■ heart disease

■ trouble urinating due to enlarged prostrate gland

■ glaucoma

■ a breathing problem such as asthma, emphysema or chronic

bronchitis

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers or any other 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

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. ►

Drug Facts (continued)

Directions

■ take only as recommended

■ Use dosage cup or tablespoon

        Age                                         Dose

Adults & children 12           One Dose = 2 tablespoons (30 mL) at bed

years & over                     time if needed or as directed by a doctor

Other information

■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg

■ dosage cup provided

■ store at room temperature

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

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

*This product is not manufactured or distributed by Procter

& Gamble, owner of the registered trademark ZzzQuil™

Manufactured by: AptaPharma Inc.,

1533 Union Ave.,

Pennsauken, NJ 08110

AP-LR-10

6 OZ

4 OZ

res

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ heart disease

■ trouble urinating due to enlarged prostrate gland

■ glaucoma

■ a breathing problem such as asthma, emphysema or chronic bronchitis


Advanced Ingredient Data


Raw Label Data

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