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| Product NDC Code | 59779-693 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nighttime cold and flu |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1298348 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | CVS Pharmacy | ||||||
| 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 30 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 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 do not take more than directed (see overdose warning) do not take more than 6 doses (180 mL) in any 24-hour period 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
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 there symptoms due to a cold minor aches and pains headache sore throat runny nose sneezing itchy, watery eyes due to hay fever nasal and sinus congestion itching of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/fever reducer Antihistamine/ Cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.NightTime Cold and Flu Acetaminophen, Diphenhydramine HCi, Phenylephrine HCi ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE
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 Theraflu® ExpressMax® Nighttime Severe Cold & Cough* Severe Cold & Cough relief ACETAMINOPHEN Pain reliever; Fever reducer DIPHENHYDRAMINE HCl Antihistamine; Cough Suppressant PHENYLEPHRINE HCl Nasal decongestant Relief of: Nasal congestion; Runny nose; Cough; Fever; Body ache; Sore throat; Headache NIGHTTIME Berry Flavor Alcohol content 10% For Ages 12 & Over FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GSK Consumer Health, distributor Theraflu® ExpressMax® Nighttime Severe Cold & Cough. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Product Label CVS HEALTH Severe Cold & Cough Berry Flavor Acetaminophen 650 mg, Diphenhydramine HCl 25 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 liver disease glaucoma heart disease thyroid disease high blood pressure diabetes cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such 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 taking the blood thinning drug warfarin sedatives or tranquilizers
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 to make a child sleepy 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 product containing diphenhydramine, even one used on skin with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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 : 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.
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, cough or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children
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 30 mL contains : potassium 10 mg each 30 mL contains : sodium 14 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 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 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 to make a child sleepy 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 product containing diphenhydramine, even one used on skin with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease glaucoma heart disease thyroid disease high blood pressure diabetes cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers When using this product do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 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