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| Product NDC Code | 55758-056 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sanatos nighttime multi symptoms |
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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 | Pharmadel LLC | ||||||
| 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 Ingredients & Purposes Active ingredients (in each 30 mL dose cup) Purposes Acetaminophen 650 mg..... Pain reliever/ fever reducer Dextromethorphan HBr 30 mg..... Cough suppressant Doxylamine succinate 12.5 mg..... Antihistamine
| Dextromethorphan HBr 30 mg..... | Cough suppressant |
| Doxylamine succinate 12.5 mg..... | Antihistamine |
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 age dose adults & children 12 years & over 30 mL(2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
| adults & children 12 years & over | 30 mL(2TBSP) 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&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene 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 these common cold/flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 30 mL dose cup) Purposes Acetaminophen 650 mg..... Pain reliever/ fever reducer Dextromethorphan HBr 30 mg..... Cough suppressant Doxylamine succinate 12.5 mg..... Antihistamine
| Dextromethorphan HBr 30 mg..... | Cough suppressant |
| Doxylamine succinate 12.5 mg..... | Antihistamine |
Spl product data elements
Usually a list of ingredients in a drug product.Sanatos Nighttime Multi Symptoms Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID FD&C GREEN NO. 3 D&C YELLOW NO. 10 SACCHARIN SODIUM SACCHARIN SODIUM BENZOATE SODIUM CITRATE PROPYLENE GLYCOL SUCROSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN
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.Princpal Display Panel PDPAPTASanatos Night
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
Distributed by: Pharmadel LLC Seaford, DE 19973 www.sanatos.com
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 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other informaiton each 30 mL dose cup contains: sodium 45 mg store at room temperature Tamper Evident: Do not use if imprinted shrink band is missing or broken.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-866-359-3478
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 fever fever gets worse or lasts more than 3 days 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.
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.Overdose warning: 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.
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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a 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. 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 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 a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin 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 Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by fever fever gets worse or lasts more than 3 days 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: 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.
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