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| Product NDC Code | 53943-501 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Original night-time multi-symptom cold/flu relief |
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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 | M012 | ||||||
| Labeler Name | Discount Drug Mart | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF
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 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 Facts Active 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 warning Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours if taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours. adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use
| adults and children 12 years and over | 30 mL (2 TBSP) every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, D and C yellow # 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 headache minor aches and pain fever runny nose and sneezing cough due to minor throat and bronchial irritation
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.Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C GREEN NO. 3 FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL 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.DISCOUNT drug mart FOOD FAIR Original Night-Time Multi-Symptom Cold/Flu Relief product label *COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ® NYQUIL ® DISCOUNT drug mart FOOD FAIR Original Night-Time Multi-Symptom Cold/Flu Relief Acetaminophen ...... Pain Reliever/Fever Reducer Dextromethorphan HBR ....... Cough Suppressant Doxylamine Succinate ........... Antihistamine 12 FL OZ (354 mL) * This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks ® Nyquil® LR-065 REV 01 SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256 501-28 Lbl
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 monamine 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
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 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 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, or headache that lasts. These could be signs of a serious condition.
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 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.DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN Failure to follow these warnings could result in serious consequences. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ● more than 4 doses in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks everyday while using this product. Allery Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ● skin reddening ● blisters ● rash If skin reaction occurs, 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