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Cough and Cold XL3 Xtra by Selder, S.A. de C.V.

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 250mg, PHENYLEPHRINE HYDROCHLORIDE 5mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-800

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 capsule)
Acetaminophen 250 mg
Phenylepherine Hydrochloride 5 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg

Purpose
Analgesic
Decongestant
Antihistamine
Antitussive

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 use •more than recommended dosage  • for pain more than 7 days • for fever more than 3 days for children under 12 years of age • with any other product containing acetaminophen

Alcohol warning 
• if you consume 3 or more alcoholic drinks every day, ask your doctor if you sghould take acetaminophenor other pain relievers/fever reducers. Acetaminophen may cause liver damage

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

Do not take this product for persistent or chronic cough such as occur with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor


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. 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 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 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by a doctor. For children under 12 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

COUGH AND COLD  XL3 XTRA
acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-800
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE ) PHENYLEPHRINE HYDROCHLORIDE5 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE ) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 600 
POLYETHYLENE GLYCOL 1000 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
Product Characteristics
Colorblue (Sky Blue) Scoreno score
ShapeCAPSULE (Soft liquid filled capsule) Size10mm
FlavorImprint CodeXtra
Contains    
Packaging
#Item CodePackage Description
1NDC:63654-800-2020 CAPSULE, LIQUID FILLED (CAPSULE) 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
Progela, S.A. de C.V.812374932manufacture
Establishment
NameAddressID/FEIOperations
Selder, S.A. de C.V.824413629manufacture

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

← See all Cough and Cold XL3 Xtra brands

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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