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Sanatos nighttime - Medication Information

Product NDC Code 55758-042
Drug Name

Sanatos nighttime

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]
Active Ingredients
Acetaminophen 325 mg/1
Dextromethorphan hydrobromide 15 mg/1
Doxylamine succinate 6.25 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1094549
Application Number M012
Labeler Name Pharmadel LLC
Packages
Package NDC Code Description
55758-042-08 1 blister pack in 1 carton (55758-042-08) / 8 capsule, liquid filled in 1 blister pack
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients and Purposes Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .............. Pain reliever/ fever reducer Dextromethorphan HBr 15 mg ...... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine
Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg .............. Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg ......Cough suppressant
Doxylamine succinate 6.25 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 do not exceed recommended dosage (see Liver warning) do not exceed 4 doses in a 24 hour period or as directed by a doctor Age Dose adults and children 12 years and older 2 softgels every 6 hours children 4 to under 12 years consult a doctor children under 4 years do not use
Age Dose
adults and children 12 years and older 2 softgels every 6 hours
children 4 to under 12 yearsconsult a doctor
children under 4 years do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, 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 and bronchial irritation sore throat headache minor aches and pains runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever and fever reducer

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .............. Pain reliever/ fever reducer Dextromethorphan HBr 15 mg ...... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine
Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg .............. Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg ......Cough suppressant
Doxylamine succinate 6.25 mg .....Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
Sanatos Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL METHYLPARABEN PROPYLPARABEN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE SN3

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.
SNightPDP

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 New Castle, DE, 19720 /PHARMADELUSA

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 glaucoma a cough that is accompanied by excessive phlegm (mucus) a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to an 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. for more than 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 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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store between 68-77°F (20-25°C) avoid excessive heat do not use if blister pack is punctured or torn

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 - 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 pain or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur cough comes back, occurs with a rash or a persistent 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 excitability may occur, especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase drowsiness effect avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 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 amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. 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. for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease glaucoma a cough that is accompanied by excessive phlegm (mucus) a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to an 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 excitability may occur, especially in children may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase drowsiness effect avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur cough comes back, occurs with a rash or a persistent 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. 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