Your browser does not support JavaScript! COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]
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RxNorm Names

COLD MEDICINE XL3 (acetaminophen chlorpheniramine maleate phenylepherine hydrochloride ) tablet
[Selder, S.A. de C.V.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients (in each capsule)
Acetaminophen 325 mg
Chlorpheniramine Maleate 4 mg
Phenylepherine Hydrochloride 10 mg

Purpose
Analgesic
Antihistamine
Decongestant

Uses  temporarily relieves these symptoms due to common cold and allergies: • nasal congestion • runny nose • sneezing • watery eyes • fever • aches and pains

Warnings
Do exceedrecommended dosage

Ask a doctor before use you have
• glaucoma • breathing problem such as emphysema or chronic bronchitis • heart disease • diabetes • thyroid disease 
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives


Stop taking this product and ask a doctor if you have • pain • fever or symptoms that persist or get worse • new symptoms occur
• redness or swelling • these may be signs of a serious condition.

When using this product
• you may get drowsy • avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
•  excitability may occur, especially in children

If nervousness, dizziness or sleeplessness occur discontinue use and consult a doctor

If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor

If pregnant or breast feeding, ask a health professional before use

Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Drug Interaction Precautions
• Do not use if you are 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.

Directions Adults and children 12 years of age and older; take 1 tablet every 4 hours, do not take more than 6 tablets in 24 hours, unless directed by a doctor.

Inactive Ingredients Lactose, stearic acid, povidone, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, FDC Yellow No. 5

Package Label
image of package label

COLD MEDICINE  XL3
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63654-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE ) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
STEARIC ACID 
POVIDONE 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 5 
Product Characteristics
Coloryellow (light yellow) Scoreno score
ShapeROUND (Tablet) Size5mm
FlavorImprint Code XL;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63654-600-6820 in 1 BLISTER PACK
2NDC:63654-600-0225 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/15/2011
Labeler - Selder, S.A. de C.V. (824413629)
Establishment
NameAddressID/FEIBusiness Operations
Selder, S.A. de C.V.824413629manufacture

Revised: 10/2011
 
Selder, S.A. de C.V.

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