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| Product NDC Code | 0363-0729 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime 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 | WALGREENS | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Daytime Cold & Flu Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Nighttime Cold & Flu Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 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 take only as directed do not exceed 4 doses per 24 hrs adults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only) 2 softgels with water every 4 hrs (Daytime only) children 4 to under 12 yrs: ask a doctor children under 4 yrs: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Daytime only) FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide. Inactive ingredients (Nighttime only) FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, 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: nasal congestion (Daytime only) cough due to minor throat & bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing (Nighttime only)
Purpose
Information about the drug product’s indications for use.Daytime Cold & Flu Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant Nighttime Cold & Flu Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Daytime Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate DAYTIME COLD AND FLU acetaminophine dextromethorphan hbr phenylphrine hcl FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SORBITAN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C YELLOW NO. 6 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SHELLAC WATER GELATIN GLYCERIN PROPYLENE GLYCOL Oblong shaped 70 NIGHTTIME COLD AND FLU acetaminophen dextromethorphan hbr doxylamine succinate FD&C BLUE NO. 1 GELATIN POVIDONE WATER POLYETHYLENE GLYCOL, UNSPECIFIED SHELLAC TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PROPYLENE GLYCOL SORBITAN ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 GLYCERIN Oblong shaped 71
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.day-night-24s-ifc
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
OTHER INFORMATION Other information store at room temperature
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 heart disease (Daytime only) high blood pressure (Daytime only) thyroid disease (Daytime only) diabetes (Daytime only) trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema (Daytime only) glaucoma (Nighttime only) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis or emphysema (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.
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 righl away (1-800-222-1222). Quick medical attention is critical for adults & 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? Call 1-877-290-4008
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 get worse or last more than 7days (Daytime 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. pain, or cough gets worse or lasts more than 7days (Nighttime only) 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 (Daytime only) excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic drinks (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, & tranquilizers may increase drowsiness (Nighttime only)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 hrs, which is the maximum daily amount for this product wilh other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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