COLD MEDICINE XL3- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet 
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 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 exceed recommended 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 Type HUMAN OTC DRUG Item Code (Source) NDC:63654-600
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE (UNII: J2B2A4N98G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND (Tablet) Size 5mm
Flavor Imprint Code XL;3
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63654-600-68 20 in 1 BLISTER PACK
2 NDC:63654-600-02 25 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/15/2011
Labeler - Selder, S.A. de C.V. (824413629)
Establishment
Name Address ID/FEI Business Operations
Selder, S.A. de C.V. 824413629 manufacture

Revised: 10/2011
Document Id: 09cc48f3-e043-4da8-a9f1-00cb6ccbee95
Set id: fc4d100b-eaa9-4e46-a27a-74094aa11d0f
Version: 1
Effective Time: 20111020
 
Selder, S.A. de C.V.