Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel COMPARE TO THERAFLU® NIGHTTIME SEVERE COLD & COUGH ACTIVE INGREDIENTS* NIGHTTIME FOR ADULTS Severe Cold & Cough Relief ACETAMINOPHEN 650 mg PAIN RELIEVER • FEVER REDUCER DIPHENHYDRAMINE HCl 25 mg ANTIHISTAMINE • COUGH SUPPRESSANT PHENYLEPHRINE HCl 10 mg NASAL DECONGESTANT RELIEVES: Cough Itchy Bose or Throat Aches, Fever & Sore Throat Runny Nose & Sneezing Itchy, Watery Eyes Nasal Congestion FOR AGES 12 + Alcohol 10 % CHERRY FLAVOR FL OZ (mL) *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., Distributor of Theraflu® Nighttime Severe Cold & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007©TOPCO QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com; Product Label TOPCARE HEALTH Severe Cold & Cough Relief Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg
- Principal Display Panel COMPARE TO THERAFLU® NIGHTTIME SEVERE COLD & COUGH ACTIVE INGREDIENTS* NIGHTTIME FOR ADULTS Severe Cold & Cough Relief ACETAMINOPHEN 650 mg PAIN RELIEVER • FEVER REDUCER DIPHENHYDRAMINE HCl 25 mg ANTIHISTAMINE • COUGH SUPPRESSANT PHENYLEPHRINE HCl 10 mg NASAL DECONGESTANT RELIEVES: Cough Itchy Bose or Throat Aches, Fever & Sore Throat Runny Nose & Sneezing Itchy, Watery Eyes Nasal Congestion FOR AGES 12 + Alcohol 10 % CHERRY FLAVOR FL OZ (mL) *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., Distributor of Theraflu® Nighttime Severe Cold & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007©TOPCO QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com
- Product Label TOPCARE HEALTH Severe Cold & Cough Relief Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg
Overview
Uses temporarily relieves these symptoms due to a cold minor aches and pains headache sore throat runny nose itchy, watery eyes sneezing nasal and sinus congestion itching of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever
Indications & Usage
Uses temporarily relieves these symptoms due to a cold minor aches and pains headache sore throat runny nose itchy, watery eyes sneezing nasal and sinus congestion itching of the nose or throat cough due to minor throat and bronchial irritation 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 Liver warnings: 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, 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 a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) 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 alcoholic 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 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 redness or swelling is present cough comes back or occurs with a 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.
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 drug 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 exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children
Stop Use & Ask a Doctor
Stop use and ask a doctor if 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 redness or swelling is present cough comes back or occurs with a 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) right away. 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 between 20-25ºC (68-77ºF). Do not refrigerate.
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