Nighttime Sleep-Aid Non-Habit Forming DIPHENHYDRAMINE HCI APTAPHARMA INC. FDA Approved Uses ■ reduces time to fall asleep if you have difficulty falling asleep ■ for relief of occasional sleeplessness

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 30 mL dose cup or 2 tablespoons) Diphenhydramine HCI 50 mg
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
Strengths
30 ml 50 mg
Quantities
354 ml 30 ml
Treats Conditions
Uses Reduces Time To Fall Asleep If You Have Difficulty Falling Asleep For Relief Of Occasional Sleeplessness

Identifiers & Packaging

Container Type UNKNOWN
UPC
0376281522242 0376281522259
UNII
TC2D6JAD40
Packaging

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 NigTimeSleepAid 6 oz label 4 oz label

Package Descriptions
  • 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 NigTimeSleepAid 6 oz label 4 oz label

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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
Purpose

Purpose Nighttime sleep-aid

When Using

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 & Ask a Doctor

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.

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.

Questions

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944


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