Nighttime Cold and Flu Relief Therapy Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride 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 SODIUM CITRATE
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel *Compare to the active ingredients in Theraflu® Nighttime Nighttime Flu Relief Therapy Cold & Cough Acetaminophen Pain reliever/fever reducer Diphenhydramine HCl antihistamine/cough suppressant Phenylephrine HCl nasal decongestant For ages 12 & over Alcohol 10% Cherry Flavor FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Novartis Consumer Health Inc.© owner of the registered trademark Theraflu® Nighttime. Failure to follow the drug facts warnings could result in serious consequences. Distributed by C.D.M.A. Inc.© 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300; Product Label Quality Choice Nighttime Flu Relief Therapy Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrinw HCl 5 mg
- Principal Display Panel *Compare to the active ingredients in Theraflu® Nighttime Nighttime Flu Relief Therapy Cold & Cough Acetaminophen Pain reliever/fever reducer Diphenhydramine HCl antihistamine/cough suppressant Phenylephrine HCl nasal decongestant For ages 12 & over Alcohol 10% Cherry Flavor FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Novartis Consumer Health Inc.© owner of the registered trademark Theraflu® Nighttime. Failure to follow the drug facts warnings could result in serious consequences. Distributed by C.D.M.A. Inc.© 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300
- Product Label Quality Choice Nighttime Flu Relief Therapy Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrinw HCl 5 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 use in infants do not exceed recmmended dose (see overdose warning) use dosage cup provided tbsp= tablespoon, mL=milliliter Do not take more than 6 doses (12 tablespoons) in 24 hours. age dose adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours children 4 to 11 years do not use unless directed by a doctor children under 4 years do not use
Warnings & Precautions
Warnings 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product. 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
Purpose 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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 15 mL contains: potassium 5 mg, sodium 7 mg store at room temperature
Questions
Questions or comments? 1-866-534-4631
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