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| Product NDC Code | 55319-813 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime nighttime severe cold and flu |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1369842, 1431245, 2637731 |
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| Application Number | part341 | ||||
| Labeler Name | Family Dollar (FAMILY WELLNESS) | ||||
| 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 15 mL) DAYTIME Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Active ingredients for (in each 30 mL) NIGHTTIME Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine Succinate 12.5 mg Phenylephrine HCL 10 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 do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use NIGHTTIME take only as directed (see Overdose warning) Do not exceed 4 doses per 24 hours measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 4 hours children under 12 years of age: do not use when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Day Time citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gum Night Time anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dihydrate, sorbitol, sucralose, xanthan gum
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 temporarily relieves common cold and flu symptoms nasal congestion sinus congestion and pressure minor aches and pain headache fever sore throat reduces swelling of nasal passages cough due to minor throat and bronchial irritation temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive NIGHTTIME temporarily relieves these common cold/flu symptoms` nasal congestion sore throat headache sinus congestion and pressure minor aches and pains runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever cough to help you sleep swelling of nasal passage temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
Purpose
Information about the drug product’s indications for use.Purposes for Day Time Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Purpose for Night Time Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Daytime Nighttime Severe Cold and Flu Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCL DoxylamineSucinate Daytime Severe Cold and Flu Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 PROPYLENE GLYCOL WATER TRISODIUM CITRATE DIHYDRATE GLYCERIN SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM Nighttime Severe Cold and Flu Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SACCHARIN SODIUM SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM
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 COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® AND NYQUIL® SEVERE COLD & FLU* SEVERE Cold & Flu Relief DAYTIME Acetaminophen (Pain Reliever / Fever Reducer) Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) Phenylephrine HCI (Nasal Decongestant) Relieves Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Cough Chest Congestion For ages 6 years and over Max Strength Non-Drowsy Alcohol Free When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing NIGHT TIME Acetaminophen (Pain Reliever / Fever Reducer) Dextromethorphan HBr (Cough Suppressant) Doxylamine Succinate (Antihistamine) Phenylephrine HCL (Nasal Decongestant) Relieves Headache, Fever, Sore Throat, Minor Aches & Pain Nasal/Sinus Congestion & Sinus Pressure Sneezing Runny Nose Cough Max Strength Alcohol Free FL OZ (mL) BERRY FLAVOR *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and NyQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY MIDWOOD BRANDS, LLC 500 VOLVO PARKWAY CHESAPEAKE, VA 23320
Product Label FAMILY WELLNESS DayTime Nigttime Severe Cold and Flu Relief Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg Phenylephrine HCL.5mg, Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Doxylamine Succinate 12.5 mg, Phenylephrine HCL 10 mg
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 DAYTIME liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet
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 DAYTIME taking the blood thinning drug warfarin. NIGHTTIME taking sedatives or tranquilizers taking the blood thinning drug warfarin
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 DAYTIME NIGHTTIME 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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. DAYTIME NIGHTTIME Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away. Quick medical attention is critical for adults as well as 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 or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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 DAYTIME nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. NIGHTTIME 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 DAYTIME do not take more than directed. NIGHTTIME do not take more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness
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 DAYTIME each 15 mL contains: sodium 12 mg store between 20-25ºC (68-77º). Do not refrigerate NIGHTTIME each 30 mL contains: sodium 64 mg store between 20-25ºC (68-77ºF). Do not refrigerate
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 DAYTIME Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 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. NIGHTTIME 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: 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 DAYTIME NIGHTTIME 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if you have DAYTIME liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are DAYTIME taking the blood thinning drug warfarin. NIGHTTIME taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product DAYTIME do not take more than directed. NIGHTTIME do not take more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. NIGHTTIME 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. DAYTIME NIGHTTIME Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away. Quick medical attention is critical for adults as well as 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