Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Multi-symptom Mapap Cold Formula Tablet, Film Coated
FDA Label NDC 0904-5786
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Multi-symptom Mapap Cold Formula (NDC 0904-5786). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- nasal congestion
- headache
- cough
- sinus congestion and pressure
- sore throat
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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
- blisters
- rash
- skin reddening
Allergy alert: Acetaminophen may cause skin reactions. Symptoms may include:
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
- 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 taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- diabetes
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- heart disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- thyroid disease
- high blood pressure
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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- adults and children 12 years and over:
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
Questions Or Comments?
(800) 616-2471
Principal Display Panel
Major®
NDC 0904-5786-24
Compare to active ingredients in Tylenol® COLD MAX*
MULTI-SYMPTOM
Mapap®
COLD FORMULA
CAPLETS
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
PHENYLEPHRINE HCl
Pain Reliever / Fever Reducer
Cough Suppressant • Nasal Decongestant
For Relief of: Fever, Headache,
Sore Throat, Nasal Congestion, Coughing
DAYTIME • NON-DROWSY
ASPIRIN FREE
24 CAPLETS with Cool Blast Flavor
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® COLD MAX. 50844 REV0316E47008
Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA M-17 Rev.09/16
Re-order No. 006363
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Major 44-470c (Major 44 470c Cms 1) 
* Please review the disclaimer below.
