Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel Major ® NDC 63187-652-24 MULTI-SYMPTOM Mapap ® COLD FORMULA CAPLETS ASPIRIN FREE ACETAMINOPHEN DEXTROMETHORPHAN HBr PHENYLEPHRINE HCl DAYTIME • NON-DROWSY Pain Reliever / Fever Reducer Cough Suppressant • Nasal Decongestant For Relief of: Fever, Headache, Sore Throat, Nasal Congestion, Coughing 24 CAPLETS with Cool Blast Flavor Compare to active ingredients in TYLENOL ® Cold Multi-Symptom Daytime* *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol ® Cold Multi-Symptom Daytime. 50844 REV0213D47008 Distributed by MAJOR ® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA M-17 Rev.02/13 Relabeled by Proficient Rx LP Thousand Oaks, CA 91320 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. 63187-652-24
- Principal Display Panel Major ® NDC 63187-652-24 MULTI-SYMPTOM Mapap ® COLD FORMULA CAPLETS ASPIRIN FREE ACETAMINOPHEN DEXTROMETHORPHAN HBr PHENYLEPHRINE HCl DAYTIME • NON-DROWSY Pain Reliever / Fever Reducer Cough Suppressant • Nasal Decongestant For Relief of: Fever, Headache, Sore Throat, Nasal Congestion, Coughing 24 CAPLETS with Cool Blast Flavor Compare to active ingredients in TYLENOL ® Cold Multi-Symptom Daytime* *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol ® Cold Multi-Symptom Daytime. 50844 REV0213D47008 Distributed by MAJOR ® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA M-17 Rev.02/13 Relabeled by Proficient Rx LP Thousand Oaks, CA 91320 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. 63187-652-24
Overview
Uses • temporarily relieves these common cold/flu symptoms: o minor aches and pains o headache o nasal congestion o cough o sore throat o sinus congestion and pressure • helps clear nasal passages • promotes nasal and sinus drainage • temporarily reduces fever
Indications & Usage
Uses • temporarily relieves these common cold/flu symptoms: o minor aches and pains o headache o nasal congestion o cough o sore throat o sinus congestion and pressure • helps clear nasal passages • promotes nasal and sinus drainage • temporarily reduces fever
Dosage & Administration
Directions • do not take more than directed (see overdose warning) • adults and children 12 years and over: o take 2 caplets every 4 hours o swallow whole - do not crush, chew, or dissolve o do not take more than 10 caplets in 24 hours • children under 12 years: ask a doctor
Warnings & Precautions
Warnings Liver warning : This product contains acetaminophen. The maximum daily dose of ths product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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. • 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 using this product. Ask a doctor before use if you have • liver disease • diabetes • heart disease • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion, or cough 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.
Purpose
Purpose Pain reliever/fever reducer 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. • 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 using this product.
When Using
When using this product do not exceed recommended dosage.
Stop Use & Ask a Doctor
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion, or cough 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.
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 • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º) • see end flap for expiration date and lot number
Questions
Questions or comments? (800) 616-2471
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