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| Product NDC Code | 68210-5030 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime non drowsy cold and flu and nighttime cold and flu |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1086997, 1094549, 2634564 |
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| Application Number | M012 | ||||
| Labeler Name | Spirit Pharmaceuticals LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Daytime Non Drowsy Cold and Flu and Nighttime Cold and flu
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients for Daytime (in each softgel) Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg Active ingredients for Nigttime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 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 (Daytime only) ■ take only as directed - see Overdose warning ■ do not exceed 4 doses per 24 hours ■ adults and children 12 years and over: take 2 softgels with water every 4 hours ■ children 4 to under 12 years: ask a doctor ■ children under 4 years: do not use ■ when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosingDirections (Nighttime only) ■ take only as directed - see Overdose warning ■ do not exceed 4 doses per 24 hours ■ adults and children 12 years and over: take 2 softgels with water every 6 hours ■ children 4 to under 12 years: ask a doctor ■ children under 4 years: do not use ■ when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients DAYTIME FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, lecithin, myglyol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide NIGHTTIME D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, 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: fever headache sore throat minor aches and pain cough due to minor throat and bronchial iffitation nasal congestion (Daytime only) runny nose and sneezing (Nighttime only)
Purpose
Information about the drug product’s indications for use.Purposes COLD & FLU NON DROWSY DAY RELIEF Pain reliever/fever reducer Cough suppressant Nasal decongestant COLD & FLU NIGHT RELIEF Pain reliever/fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Daytime Non Drowsy Cold and Flu and Nighttime Cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride Daytime Non Drowsy Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN LECITHIN, SOYBEAN MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL 400 POVIDONE PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 512;A09;AP01 Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN LECITHIN, SOYBEAN MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL 400 POVIDONE PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 215;902;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 Carton
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 ● cough that occurs with too much phlegm (mucus) ● liver disease ● trouble urinating due to enlarged prostate gland ● diabetes (Daytime only) ● heart disease (Daytime only) ● thyroid disease (Daytime only) ● high blood pressure (Daytime only) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only) ● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only) ● glaucoma (Nighttime only)
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 the blood thinning drug warfarin ● taking sedatives or tranquilizers (Nighttime only)
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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● to make a child sleepy (Nighttime only)
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.
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? 1-888-333-9792
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 (Daytime only) ● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only) ● pain or cough gets worse or lasts more than 7 days (Nighttime only) ● 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 take more than directed ● marked drowsiness may occur (Nighttime only) ● avoid alcoholic drinks (Nighttime only) ● excitability may occur, especially in children (Nighttime only) ● be careful when driving a motor vehicle or operating machinery (Nighttime only) ● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 hours, 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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