XL3 XTRA- acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled
Teresa Cecena DBA Genesis
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 Ingredient in each capsule
Acetaminophen 250mg
Phenylepherine Hydrochloride 5mg
Chlorpheniramide Maleate 2mg
Dextromethorphan Hydrobromide 10mg
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
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
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.
XL3 XTRA
acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled |
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Labeler - Teresa Cecena DBA Genesis (078760958) |
Registrant - Teresa Cecena (078760958) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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TERESA CECENA | 078760958 | relabel(69772-440) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Selder SA DE CV | 824413629 | manufacture(69772-440) |