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| Product NDC Code | 53041-633 | ||||
|---|---|---|---|---|---|
| Drug Name | Nighttime sleep-aid |
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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 | part338 | ||||
| Labeler Name | Guardian Drug Company | ||||
| Packages |
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Overdosage of Nighttime Sleep-Aid
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT(S) Diphenhydramine HCl 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 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
| 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 |
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, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.
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.USE(S) for relief of occasional sleeplessness helps you to fall asleep if you have difficulty falling asleep
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 Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 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
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.PRINCIPAL DISPLAY PANEL NDC 53041-633-58 *Compare to the active ingredient in ZZZQUI L ® Nighttime Sleep-Aid Nighttime Sleep-Aid Warming Berry Flavor Relieves : Occasional Sleeplessness 6 FL OZ (177 ML) gdc-633-6oz
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 a breathing problem such as emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
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 .
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 (2 Tbsp) contain: sodium 30 mg store at room temperature protect from light
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 DOCTOR IF sleepleness persists continuously for more than two 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 avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery
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 .
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