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Multi-Symptom Mapap Cold Formula

Medically reviewed on November 21, 2016

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5786

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Major 44-470C-CMS

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

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

Allergy alert: Acetaminophen may cause skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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


MULTI-SYMPTOM MAPAP COLD FORMULA 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5786
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POVIDONE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;470
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5786-242 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2005
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-5786)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-5786)

 
Major Pharmaceuticals

← See all Multi-Symptom Mapap Cold Formula brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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