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| Product NDC Code | 82501-1579 | ||||
|---|---|---|---|---|---|
| Drug Name | Cold and flu non drowsy day relief and night relief |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1086997, 1297288, 1426334, 2634363 |
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| Application Number | M012 | ||||
| Labeler Name | Gobrands, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Cold and Flu Non Drowsy Day Relief and Night Relief
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 (in each softgel) COLD & FLU NON-DROWSY DAY RELIEF Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg COLD & FLU NIGHT RELIEF Acetaminophen 325 mg Dextromethorphan hydrobromide 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 ● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing Directions (Daytime only) ● take only as directed - see Overdose warning ● do not exceed 4 doses per 24 hours adults & children 12 years & over take 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years of age do not use ● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing Directions (Nighttime only) ● take only as directed - see Overdose warning ● do not exceed 4 doses per 24 hours adults & children 12 years & over take 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years of age do not use
| adults & children 12 years & over | take 2 softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years of age | do not use |
| adults & children 12 years & over | take 2 softgels with water every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years of age | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients DAY RELIEF FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide*, MYGLYOL 812*, lecithin* *May Contain one or more of these ingredients NIGHT RELIEF D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb*, sorbitol 70% solution*, titanium dioxide*, MYGLYOL 812*, lecithin*, *May Contain one or more of these ingredients
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 minor aches and pain cough due to minor throat and bronchial iffitation sore throat 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.Cold and Flu Non Drowsy Day Relief and Night Relief acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride Cold and Flu Non Drowsy Day Relief acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE PROPYLENE GLYCOL SORBITOL TITANIUM DIOXIDE LECITHIN, SOYBEAN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 512;A09 Cold and Flu Night Relief acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE LECITHIN, SOYBEAN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 116;A07
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 Cold and flu day and night
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. 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) 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 a doctor or pharmacist before use if you are ● taking the blood thinning drug warfarin ● taking sedatives or tranquilizers (Nighttime only) 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) 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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