Flu and Severe Cold Nighttime Relief Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 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
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel *Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough* Nighttime Relief Flu & Severe Cold Acetaminophen Pain reliever; fever reducer Diphenhydramine HCl Cough suppressant; antihistamine Phenylephrine HCl Nasal decongestant Relief of: Nasal congestion; runny nose; cough; fever; body ache; sore throat; headache Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895 CVS.com 1-800-SHOP CVS Alcohol Content: 10% Cherry Flavor For ages 12 & over FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. Failure to follow the drug facts warnings could result in serious consequences. *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.; Product Label CVS Nighttime Flu and Severe Cold Liquid Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg
- Principal Display Panel *Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough* Nighttime Relief Flu & Severe Cold Acetaminophen Pain reliever; fever reducer Diphenhydramine HCl Cough suppressant; antihistamine Phenylephrine HCl Nasal decongestant Relief of: Nasal congestion; runny nose; cough; fever; body ache; sore throat; headache Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895 CVS.com 1-800-SHOP CVS Alcohol Content: 10% Cherry Flavor For ages 12 & over FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. Failure to follow the drug facts warnings could result in serious consequences. *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.
- Product Label CVS Nighttime Flu and Severe Cold Liquid Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg
Overview
Uses temporarily relieves minor aches and pains sneezing headache minor sore throat pain itchy, watery eyes nasal and sinus congestion runny nose cough due to minor throat and bronchial irritation itchy nose or throat temporarily reduces fever
Indications & Usage
Uses temporarily relieves minor aches and pains sneezing headache minor sore throat pain itchy, watery eyes nasal and sinus congestion runny nose cough due to minor throat and bronchial irritation itchy nose or throat temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning) do not take more than 6 doses 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
Warnings & Precautions
Warnings Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 product 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 accompanied by excessive 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 use more than directed (see overdose warning) avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if redness or swelling is present nervousness, dizziness, or sleeplessness occurs 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 cough comes back or occurs with a fever, 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) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose
Purposes Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant
Do Not Use
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 product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
When Using
When using this product do not use more than directed (see overdose warning) avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Stop Use & Ask a Doctor
Stop use and ask a doctor if redness or swelling is present nervousness, dizziness, or sleeplessness occurs 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 cough comes back or occurs with a fever, 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. 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) immediately. Quick 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 30 mL contains: potassium 10 mg each 30 mL contains: sodium 14 mg store at 20-25ºC (68-77ºF). Do not refrigerate.
Questions
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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