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| Product NDC Code | 57243-501 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nite-time cold/flu original |
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| Type | Brand | ||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1043400 | ||||||
| Application Number | M013 | ||||||
| Labeler Name | Salado Sales, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Nite-Time COLD/FLU ORIGINAL
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose Warning Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug FactsActive ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 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-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours AptaPharma NiteTime2 Label
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
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 temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Nite-Time COLD/FLU ORIGINAL ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 FD&C GREEN NO. 3 FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL 400 WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE
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.Product Label Compare to VICKS® NYQUIL® active ingredients CVP CONSUMER VALUE PRODUCTS Nite-Time COLD/FLU Medicine Multi-Symptom ORIGINAL FLAVOR Acetaminophen ..........................Aches, Fever and Sore Throat Dextromethorphan ......................Cough Doxylamine Succinate ................Sneezing, Runny nose 6 FL OZ (177 mL) DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN *This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-002 Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944 Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503 www.saladosales.com LOT: EXP: Peel Here DRUG FACTS CONTINUED ON BACK ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine Antihistamine Cough Suppressant Pain Reliever Fever Reducer res AptaPharma Night-Time Label
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 sodium restricted diet liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland
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 if you are taking the blood thinning drug warfarin
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 with any other drug containing acetaminophen (prescription or nonprescription) If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product to make a child sleepy
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 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 dose cup contains: sodium 45 mg store at room temperature
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 redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
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 drinks excitability may occur, especially in children marked drowsiness may 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 feedingPregnant 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 Failure to follow these warnings could result in serious consequences Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amoun with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening blisters rash If a skin reaction ccurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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