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| Product NDC Code | 70677-1028 | ||||
|---|---|---|---|---|---|
| Drug Name | Foster and thrive daytime cold and flu relief nighttime cold and flu relief |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1086997, 1094549, 2634564 |
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| Application Number | M012 | ||||
| Labeler Name | Strategic Sourcing Services LLC | ||||
| 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 softgel) – Nighttime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
Active ingredients (in each softgel) – Daytime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 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 – Nighttime Cold & Flu • take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Directions – Daytime Cold & Flu • take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs 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 – Nighttime Cold & Flu D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Inactive ingredients – Daytime Cold & Flu edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
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 – Nighttime Cold & Flu temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing
Uses – Daytime Cold & Flu temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever
Purpose
Information about the drug product’s indications for use.Purpose – Nighttime Cold & Flu Pain reliever/fever reducer Cough suppressant Antihistamine
Purpose – Daytime Cold & Flu Pain reliever/fever reducer Cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.foster and thrive daytime cold and flu relief nighttime cold and flu relief Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl foster and thrive nighttime cold and flu relief Acetaminophen, dextromethorphan HBr, doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN clear 056 foster and thrive daytime cold and flu relief Acetaminophen, dextromethorphan HBr, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN L994
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.Package/Label Principal Display Panel COMPARE TO VICKS ® DAYQUIL ® COLD & FLU ACTIVE INGREDIENTS Foster & Thrive™ DAYTIME Cold & Flu Relief Acetaminophen Dextromethorphan HBr Phenylephrine HCl PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, NASAL DECONGESTANT Alcohol Free | Antihistamine Free | Gluten Free Non-Drowsy Multi-Symptom Relief of: • Aches/Fever • Sore Throat • Nasal Congestion • Cough • Headache 32 SOFTGELS ACTUAL SIZE COMPARE TO VICKS ® NYQUIL ® COLD & FLU ACTIVE INGREDIENTS Foster & Thrive™ NIGHTTIME Cold & Flu Relief Acetaminophen Dextromethorphan HBr Doxylamine succinate PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE Alcohol Free | Gluten Free Multi-Symptom Relief of: • Aches/Fever • Sore Throat • Sneezing • Runny Nose • Cough • Headache 16 SOFTGELS ACTUAL SIZE 580-km-daytime-nighttime-cold-and-flu-relief
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 – Nighttime Cold & Flu • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you have – Daytime Cold & Flu • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema
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 Cold & Flu • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu 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 • 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
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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 833-358-6431 Monday to Friday 9:00am to 7:00pm 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 – Nighttime Cold & Flu • pain 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.
Stop use and ask a doctor if – Daytime Cold & Flu • you get nervous, dizzy or sleepless • 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 – Nighttime Cold & Flu • 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
When using the product – Daytime Cold & Flu do not use more than directed
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 20-25°C (68-77°F)
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: • 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, lasts 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 Ask a doctor before use if you have – Nighttime Cold & Flu • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland Ask a doctor before use if you have – Daytime Cold & Flu • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu • taking sedatives or tranquilizers • taking the blood thinning drug warfarin Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu taking the blood thinning drug warfarin When using this product – Nighttime Cold & Flu • 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 When using the product – Daytime Cold & Flu do not use more than directed Stop use and ask a doctor if – Nighttime Cold & Flu • pain 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. Stop use and ask a doctor if – Daytime Cold & Flu • you get nervous, dizzy or sleepless • 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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