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Daytime cold and flu relief - Medication Information

Product NDC Code 76162-065
Drug Name

Daytime cold and flu relief

Type Generic
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
Acetaminophen 325 mg/1
Dextromethorphan hydrobromide 10 mg/1
Phenylephrine hydrochloride 5 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1086997
Application Number M012
Labeler Name TopCo Associates, LLC
Packages
Package NDC Code Description
76162-065-16 1 blister pack in 1 carton (76162-065-16) / 16 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 ingredient(s) Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

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 in 24 hours adults and children 12 years & over: 2 softgels with water every 4 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 FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink

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.
Use(s) temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever

Purpose

Information about the drug product’s indications for use.
Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
Daytime Cold and Flu Relief Daytime Cold and Flu Relief ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL SOLUTION PC9

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 Daytime Cold and Flu Daytime Cold and Flu

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.
Other information store at room temperature 20-25 °C (68-77° F) do not use if blister unit is torn or open

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 • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough 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 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 drugs. 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 Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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/Comments Call 1-888-952-0050 Monday through Friday 9AM - 5PM

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 • you get nervous, dizzy or sleepless • symptoms get worse or last more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more than 3 days • redness or swelling is present •new symptoms occur • 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 use more than directed

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding, 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 hrs, which is the maximum daily amount for this product • 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, occurs with or is 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 drugs. 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 • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if taking the blood thinning drug warfarin. When using this product do not use more than directed Stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms get worse or last more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more than 3 days • redness or swelling is present •new symptoms occur • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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