Cold Medicine XL-3 for Children

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-700

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.

Drug Facts

Active Ingredients (in each tablet)
Acetaminophen 80 mg
Chlorpheniramine Maleate 2 mg
Phenylepherine Hydrochloride 5 mg

Purpose
Analgesic
Antihistamine
Decongestant


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

Warnings
Do not exceed recommended dosage  because at higher dosages nervousness, dizziness, or sleeplessness may occur. Do not give the product for more than 5 days.

If symptoms persist, or if new ones occur consult a doctor.

If fever persists for more than 3 days (72 hours), or recurs, consult a doctor.

Drink water with each dose

Do not give this product at least after 7 days after a tonsillectomy or oral surgery, unless directed by a doctor.

May cause drowsiness

Do not give to children who have asthma or glaucoma, unless directed by a doctor.

Do not give this product to children who have heart disease, high blood pressure, thyroid disease or diabetes, unless directed by a doctor.



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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Drug Interaction Precautions
Do not give this product to a child who is taking a prescription drug for high blood pressure  or depression, without  first consulting a doctor

Directions Children 6 years of age to under 12 years: take 1 tablet every 4 hours, do not take more than 6 tablets in 24 hours, unless directed by a doctor. Children under 6 years of age, consult a doctor

Inactive Ingredients DC Red No. 33, FDC Blue No. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water

Package Label

COLD MEDICINE  XL-3 FOR CHILDREN
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-700
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE ) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE ) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C BLUE NO. 1 
ALCOHOL 
ASCORBIC ACID 
DEXTRATES 
GLYCERYL BEHENATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SUCRALOSE 
Product Characteristics
Colorpurple (Blueberry) Scoreno score
ShapeROUND (Tablet) Size5mm
FlavorBLUEBERRY (Artificial Blueberry Flavor) Imprint CodeXL;3;INFANTIL
Contains    
Packaging
#Item CodePackage Description
1NDC:63654-700-0120 TABLET, CHEWABLE (TABLET) 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/FEIOperations
Selder, S.A. de C.V.824413629manufacture

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

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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