Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 55758-010 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sanatos severe cold and cough day time |
||||||||
| Type | Brand | ||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
||||||||
| Active Ingredients |
|
||||||||
| Route | ORAL | ||||||||
| Dosage Form | GRANULE, FOR SOLUTION | ||||||||
| Application Number | M012 | ||||||||
| Labeler Name | Pharmadel LLC | ||||||||
| Packages |
|
||||||||
| 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 (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCI 10 mg Nasal decongestant
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCI 10 mg | Nasal decongestant |
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 do not exceed recommended dosage take every 4 hours; do not exceed 6 packets in a 24-hour period dissolve contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutes if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults & children 12 yrs. of age & over one packet every 4 hours children under 12 yrs. of age do not use
Age Dose adults & children 12 yrs. of age & over one packet every 4 hours children under 12 yrs. of age do not use
| adults & children 12 yrs. of age & over | one packet every 4 hours |
| children under 12 yrs. of age |
| adults & children 12 yrs. of age & over | one packet every 4 hours |
| children under 12 yrs. of age |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue 1, FD&C red 40, flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water
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 common cold/flu symptoms: cough due to minor throat & bronchial irritation headache sore throat minor aches & pains nasal congestion due to hay fever other upper respiratory allergies sinus congestion and pressure stuffy nose reduces fever
Purpose
Information about the drug product’s indications for use.Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCI 10 mg Nasal decongestant
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCI 10 mg | Nasal decongestant |
Spl product data elements
Usually a list of ingredients in a drug product.SanaTos Severe Cold and Cough Day Time Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride ISOPROPYL ALCOHOL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WATER
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 SanaTos ® Severe COLD & COUGH NDC 55758-010-01 NDC 55758-010-06 Box
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/ Distribuido por: PHARMADEL Georgetown, DE 19947 Made in India
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 liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma 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 taking the blood thinning drug warafin
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 (MAOIs) (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. for more than 7 days for pain and 3 days for fever, unless directed by a doctor
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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-866=359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
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 a persistent cough or symptoms do not improve within 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each packet contains: potassium 10 mg, sodium 27 mg phenylketonurics: contains phenylalanine 14 mg per packet store at room temperature 68-77°F (20-25°C) protect from excessive heat and moisture TAMPER EVIDENT: Do not use if packets are broken or torn.
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 6 packets in 24 hours, which is the maximum daily amount 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 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 (MAOIs) (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. for more than 7 days for pain and 3 days for fever, unless directed by a doctor Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if taking the blood thinning drug warafin Stop use and ask a doctor if a persistent cough or symptoms do not improve within 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur If pregnant or breast-feeding, ask a health care professional before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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