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| Product NDC Code | 41250-848 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Severe cough and congestion and cold and flu daytime, nighttime |
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| Type | Brand | ||||||
| Dosage Form | KIT | ||||||
| RxCUI drug identifier | 1233575, 1372652, 2634815 |
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| Application Number | M012 | ||||||
| Labeler Name | Meijer Distribution Inc | ||||||
| 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.Active ingredients (in each caplet) (Daytime Severe Congestion & Cough) Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Active ingredients (in each caplet) (Nighttime Cold & Flu) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 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 use more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets 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 (Daytime only) corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients (Nighttime only) corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, 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 (Daytime only) temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants nasal congestion due to a cold the intensity of coughing helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Uses (Nighttime only) temporarily relieves these common cold and flu symptoms: headache sore throat nasal congestion runny nose and sneezing cough minor aches and pains temporarily reduces fever controls cough to help you get to sleep
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant Expectorant Nasal decongestant
Purpose Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Severe Cough and Congestion and Cold and Flu Daytime, Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl Severe Cough and Congestion Daytime Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN FD&C BLUE NO. 2--ALUMINUM LAKE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE Maroon 44;648 Cold and Flu Nighttime Acetaminophen. Diphenhydramine HCl, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2--ALUMINUM LAKE FERRIC OXIDE YELLOW MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM BICARBONATE STEARIC ACID TALC TITANIUM DIOXIDE 44;694
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 COMBO PACK Total 30 Caplets NDC 41250-848-01 Meijer® Compare to Maximum Strength Mucinex ® FAST-MAX ® DAY TIME Severe Congestion & Cough active ingredients* Daytime severe cough & congestion Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Cough Suppressant Expectorant Nasal Decongestant MAXIMUM STRENGTH • Controls Cough, • Relieves Nasal & Chest Congestion • Thins & Loosens Mucus 20 Caplets Actual Size Meijer® Compare to Maximum Strength Mucinex ® FAST-MAX ® NIGHT TIME Cold & Flu active ingredients* Nighttime cold & flu Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg Pain Reliever/Fever Reducer Antihistamine/Cough Suppressant Nasal Decongestant MAXIMUM STRENGTH • Relieves Aches, Fever & Sore Throat • Relieves Nasal Congestion, Runny nose & Sneezing • Controls Cough 10 Caplets Actual Size *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX® Day Time Severe Congestion & Cough and Night Time Cold & Flu. 50844 REV1021B64869401 DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Meijer 44-648694 Meijer 44-648694
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 heart disease diabetes thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis ( Nighttime only) glaucoma (Nighttime only) liver disease (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 (Nighttime only) taking the blood thinning drug warfarin taking sedatives or tranquilizer
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 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only) if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only) with any other product containing diphenhydramine, even one used on skin (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. In case of accidental 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. Do not take DAYTIME and NIGHTTIME products at the same time.
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? 1-800-426-9391
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 nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever (Daytime only) redness or swelling is present (Nighttime only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only) new symptoms occur (Nighttime only) fever gets worse or lasts more than 3 days (Nighttime only) 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 (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) avoid alcoholic beverages (Nighttime only) marked drowsiness may occur (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 TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 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 (Nighttime only) Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash 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 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only) if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only) with any other product containing diphenhydramine, even one used on skin (Nighttime only) Ask a doctor before use if you have heart disease diabetes thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis ( Nighttime only) glaucoma (Nighttime only) liver disease (Nighttime only) Ask a doctor or pharmacist before use if you are (Nighttime only) taking the blood thinning drug warfarin taking sedatives or tranquilizer When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) avoid alcoholic beverages (Nighttime only) marked drowsiness may occur (Nighttime only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever (Daytime only) redness or swelling is present (Nighttime only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only) new symptoms occur (Nighttime only) fever gets worse or lasts more than 3 days (Nighttime only) 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 accidental 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. Do not take DAYTIME and NIGHTTIME products at the same time.
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