COLD MEDICINE XL-3 FOR CHILDREN- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet, chewable 
Selder, S.A. de C.V.

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.

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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

image of 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALCOHOL (UNII: 3K9958V90M)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
DEXTRATES (UNII: G263MI44RU)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
Product Characteristics
Colorpurple (Blueberry) Scoreno score
ShapeROUND (Tablet) Size5mm
FlavorBLUEBERRY (Artificial Blueberry Flavor) Imprint Code XL;3;INFANTIL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63654-700-0120 in 1 BLISTER PACK; Type 0: Not a Combination Product11/15/201105/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/15/201105/26/2016
Labeler - Selder, S.A. de C.V. (824413629)
Establishment
NameAddressID/FEIBusiness Operations
Selder, S.A. de C.V.824413629manufacture(63654-700)

Revised: 3/2018
 
Selder, S.A. de C.V.