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XL3 XTRA

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 1mg, PHENYLEPHRINE HYDROCHLORIDE 5mg in 1mg, ACETAMINOPHEN 250mg in 1mg, CHLORPHENIRAMINE MALEATE 2mg in 1mg
Labeler: Teresa Cecena DBA Genesis
NDC Code: 69772-440

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 Ingredient in each capsule

Acetaminophen 250mg

Phenylepherine Hydrochloride 5mg

Chlorpheniramide Maleate 2mg

Dextromethorphan Hydrobromide 10mg

PURPOSE

Analgesic

Decongestant

Antihistamine

Antitussive

USES

Temporaruly relieves the 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 age with any other product containing acetaminophen.

Alcohol Warning:If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relivers fever reducers. Acetaminophen may casuse liver damage

Ask a doctor befor use you have

  • Glaucoma, breathing problems such as emphysema or chronic bronchitis, heart disease, diabetes, thyroid disease.
  • difficulty in urination due to enlagement 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 (mucis) unless directed by doctor

Stop taking this product and ask a doctor if yoi have pain, fever or sympoms that persist or get worse ,

new symptoms occur

redness or swelling these may be 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
  • excitabiloty may occur, especially in children

if nervousness, dizziness or spleeplessness occur discontinue use and consult a doctor

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

if you are 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 contac a poison control center immediately. Prompt medical attention is critical for adults as well as children ever if you do not notice any sings or symptoms .

Drug unteraction precautions

do not use if you are taking a prescription monoamine oxidase ihibitor (MAOI) (certain drug for depression, psychoatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your presctiption 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 doctor. For children under 12 years of age consult a doctor

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

WARNINGS

DO NOT USE More than recommended dosage for pain more than 7 days for fever more than 3 days for children under 12 age with any other product containing acetaminophen.

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 doctor. For children under 12 years of age consult a doctor

XL3 XTRA 
acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-440
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 1 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 1 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg  in 1 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg  in 1 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
ColorblueScorescore with uneven pieces
ShapeCAPSULE (SOFT LIQUID FILLED CAPSULE) Size10mm
FlavorImprint CodeXtra
Contains    
Packaging
#Item CodePackage Description
1NDC:69772-440-0120 mg in 1 BLISTER PACK
2NDC:69772-440-0212 mg in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/07/2015
Labeler - Teresa Cecena DBA Genesis (078760958)
Registrant - Teresa Cecena (078760958)
Establishment
NameAddressID/FEIOperations
TERESA CECENA078760958relabel(69772-440)
Establishment
NameAddressID/FEIOperations
Selder SA DE CV824413629manufacture(69772-440)

 
Teresa Cecena DBA Genesis

Medically reviewed on Aug 7, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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