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| Product NDC Code | 79903-236 | ||||
|---|---|---|---|---|---|
| Drug Name | Cold and flu daytime nighttime |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1110988, 1233575, 2634816 |
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| Application Number | M012 | ||||
| Labeler Name | WALMART 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 Cold & Flu) Acetaminophen 325 mg 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 take 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, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, 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 temporarily relieves these common cold and flu symptoms: headache minor aches and pains nasal congestion cough sore throat sinus congestion and pressure runny nose and sneezing (Nighttime only) itching of the nose or throat (Nighttime only) itchy, watery eyes due to hay fever (Nighttime only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only) controls cough to help you get to sleep temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purpose (Daytime Cold & Flu)) Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Purpose (Nighttime Cold & Flu) Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Cold and Flu Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl Cold and Flu Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSPOVIDONE, UNSPECIFIED FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE 44;617 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 equate™ NDC 79903-236-20 Compare to Maximum Strength Mucinex® FAST-MAX® Day Time Cold & Flu & Night Time Cold & Flu active ingredients* DAYTIME Cold & Flu Acetaminophen- Pain Reliever/ Fever Reducer, Dextromethorphan HBr - Cough Suppressant Guaifenesin - Expectorant Phenylephrine HCl - Nasal Decongestant MAXIMUM STRENGTH • Relieves headache, body pain, sore throat, fever, cough, nasal & chest congestion, sinus congestion & pressure 12 Caplets Actual Size NIGHTTIME Cold & Flu Acetaminophen - Pain Reliever/ Fever Reducer, Diphenhydramine HCl - Antihistamine/ Cough Suppressant Phenylephrine HCl - Nasal Decongestant MAXIMUM STRENGTH • Relieves headache, body pain, sore throat, fever, cough, itchy throat, nasal congestion, sneezing, runny nose 8 Caplets Actual Size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX® Day Time Cold & Flu and Night Time Cold & Flu. 50844 ORG082361769409 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Do not take Daytime and Nighttime caplets at the same time. Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915 . Equate_44-617694-09_Cold_and_Flu Equate_44-617694-09_Cold_and_Flu
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 thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (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 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 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? 1-888-287-1915
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 pain, nasal congestion, or cough gets worse or lasts more than 7 days 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 exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) use caution when driving a motor vehicle or operating machinery (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 each caplet contains: sodium 3 mg (Daytime only ) 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) see end flap for expiration date and lot number
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 4,000 mg of acetaminophen in 24 hours 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: 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 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 with any other product containing diphenhydramine, even one used on skin (Nighttime only) Ask a doctor before use if you have heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (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 exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days 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. In case of 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