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| Product NDC Code | 76281-522 | ||||||||
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| Drug Name | Nighttime sleep-aid non-habit forming |
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| Type | Brand | ||||||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1248354 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | AptaPharma Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 30 mL dose cup or 2 tablespoons) Diphenhydramine HCI 50 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ reduces time to fall asleep if you have difficulty falling asleep ■ for relief of occasional sleeplessness
Purpose
Information about the drug product’s indications for use.Purpose Nighttime sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Nighttime Sleep-Aid Non-Habit Forming Diphenhydramine HCI DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each 30 mL dose (2 tablespoons) contains: sodium 23 mg ■ dosage cup provided ■ store at room temperature
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API