Multi-Symptom Mapap Cold Formula
Multi-Symptom Mapap Cold Formula is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL manufactured by Proficient Rx LP administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231101.
- Generic name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
- Manufacturer
- Proficient Rx LP
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 63187-652
- Application
- M012
- Label effective
- 20231101
Active ingredients
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
Contraindications
Not available.
Warnings
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.
Adverse Reactions
Not available.