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Multi-Symptom Mapap Cold Formula

Medically reviewed on February 1, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Proficient Rx LP
NDC Code: 63187-652

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/flu symptoms:
minor aches and pains
headache
nasal congestion
cough
sore throat
sinus congestion and pressure
helps clear nasal passages
promotes nasal and sinus drainage
temporarily reduces fever 

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. 

Directions
do not take more than directed (see overdose warning)
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
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º)
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 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.

Major 44-470C

MULTI-SYMPTOM MAPAP COLD FORMULA 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-652(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 
POLYVINYL ALCOHOL 
POVIDONES 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorMINTImprint Code44;470
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-652-242 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 - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-652)

 
Proficient Rx LP

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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