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Cold and flu nighttime - Medication Information

Product NDC Code 79903-119
Drug Name

Cold and flu nighttime

Type Brand
Pharm Class 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 650 mg/20ml
Dextromethorphan hydrobromide 20 mg/20ml
Triprolidine hydrochloride 2.5 mg/20ml
Route ORAL
Dosage Form SOLUTION
RxCUI drug identifier 2173667
Application Number M012
Labeler Name WALMART INC.
Packages
Package NDC Code Description
79903-119-45 177 ml in 1 bottle, plastic (79903-119-45)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Triprolidine HCl 2.5 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 do not take more than directed do not take more than 4 doses in any 24-hour period mL = milliliter only use the dose cup provided adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

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 and flu symptoms: cough headache runny nose sneezing sore throat itching of the nose or throat minor aches and pains itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep

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.
Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Triprolidine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE XANTHAN GUM MIXED

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 equate ™ NDC 79903-119-45 Compare to Mucinex ® Nightshift ® Cold & Flu active ingredients * NIGHTTIME Cold & Flu • Acetaminophen - Pain Reliever/Fever Reducer • Dextromethorphan HBr - Cough Suppressant • Triprolidine HCl - Antihistamine Relieves: • Cough, fever • Sore throat • Runny nose, sneezing Ages 12+ 6 FL OZ (177 mL) F-063-45 REVB PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Mucinex ® NIGHTSHIFT ® COLD & FLU. 50844 REV0423B06345 Equate 44-063 Equate 44-063

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) difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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 have ever had an allergic reaction to this product or any of its ingredients 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. In case of 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? 1-888-287-1915

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 new symptoms occur redness or swelling is present cough comes back or occurs with 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 exceed recommended dosage excitability may occur, especially in children avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

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 every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: rash blisters skin reddening 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 have ever had an allergic reaction to this product or any of its ingredients 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) difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema 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 exceed recommended dosage excitability may occur, especially in children avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness 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 7 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with 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. In case of 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