Cold and Flu Severe Night Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SODIUM METABISULFITE SORBITOL SUCRALOSE XANTHAN GUM mixed
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal display panel NDC 79395-011-45 Fluent ™ Cold+Flu Severe NIGHT Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain Reliever/Fever Reducer Antihistamine/ Cough Suppressant Nasal Decongestant Maximum Strength BERRY FLAVOR 6 FL OZ (177 mL) F-011-45 ORG TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed By: Chalkboard Health, Inc. Princeton, NJ 08540 getfluenthealth.com 50844 ORG082001145 Fluent 44-011 Fluent 44-011
- Principal display panel NDC 79395-011-45 Fluent ™ Cold+Flu Severe NIGHT Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain Reliever/Fever Reducer Antihistamine/ Cough Suppressant Nasal Decongestant Maximum Strength BERRY FLAVOR 6 FL OZ (177 mL) F-011-45 ORG TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed By: Chalkboard Health, Inc. Princeton, NJ 08540 getfluenthealth.com 50844 ORG082001145 Fluent 44-011 Fluent 44-011
Overview
Uses temporarily relieves these common cold and flu symptoms: nasal congestion minor aches and pains runny nose and sneezing sinus congestion and pressure itching of the nose or throat itchy, watery eyes due to hay fever headache cough sore throat temporarily reduces fever controls cough to help you get to sleep
Indications & Usage
Uses temporarily relieves these common cold and flu symptoms: nasal congestion minor aches and pains runny nose and sneezing sinus congestion and pressure itching of the nose or throat itchy, watery eyes due to hay fever headache cough sore throat temporarily reduces fever controls cough to help you get to sleep
Dosage & Administration
Directions do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use
Warnings & Precautions
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. with any other product containing diphenhydramine, even one used on skin 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 cough that occurs with too much phlegm (mucus) glaucoma thyroid disease heart disease difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes persistent or chronic cough such as occurs with smoking, asthma, or emphysema liver disease a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness, or sleeplessness 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. 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.
Purpose
Purpose Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Do Not Use
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. with any other product containing diphenhydramine, even one used on skin 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
When Using
When using this product do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness, or sleeplessness 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.
Keep Out of Reach of Children
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.
Storage & Handling
Other information each 20 mL contains: sodium 9 mg use by expiration date on package store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Questions
Questions or comments? 1-800-426-9391
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