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Tabcin night - Medication Information

Product NDC Code 69729-153
Drug Name

Tabcin night

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 OPMX LLC
Packages
Package NDC Code Description
69729-153-10 1 blister pack in 1 carton (69729-153-10) / 10 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 (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine
Active ingredients (in each Softgels)Purpose
Acetaminophen 325 mgPain reliever/Fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

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 directed Do not exceed 4 doses per 24 hrs Adults & children 12 yrs & over 2 softgels with water every 6 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use
Adults & children 12 yrs & over2 softgels with water every 6 hrs
Children 4 to under 12 yrsAsk a doctor
Children under 4 yrsDo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

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 Sore throat Headache Minor aches & pains Fever Runny nose & sneezing

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine
Active ingredients (in each Softgels)Purpose
Acetaminophen 325 mgPain reliever/Fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
tabcin NIGHT Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN AP02

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 NDC 69729-153-10 tabcin NIGHT Night-time Relief Cough & Flu/ Tos y Gripe Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Headache/ Dolor de cabeza Fever/ Fiebre Sore Throat/ Dolor de Garganta Sneezing/ Estornudos Runny Nose/ Secreción Nasal Cough/ Tos 10 Softgels/ 10 Cápsulas Blandas de Gel Nightt

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

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 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 tranquilizer. Taking the 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.

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST

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 7 days Fever gets worse or lasts more than 3 days Redness or swelling is present Cough comes back or occurs with rash or headache that lasts. New symptoms occur. 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 Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store at room temperature

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 hrs, 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 Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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. Ask a doctor before use if you have 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 tranquilizer. Taking the thinning drug warfarin When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness Stop use and ask a doctor if Pain or cough gets worse or lasts more than 7 days Fever gets worse or lasts more than 3 days Redness or swelling is present Cough comes back or occurs with rash or headache that lasts. New symptoms occur. These could be signs of a serious condition. Keep out of reach of children. Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use. Overdose warning Taking more than directed 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 & 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