XL3 XTRA- acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled

XL3 XTRA by

Drug Labeling and Warnings

XL3 XTRA by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis, Teresa Cecena, TERESA CECENA, Selder SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredient in each capsule

Acetaminophen 250mg

Phenylepherine Hydrochloride 5mg

Chlorpheniramide Maleate 2mg

Dextromethorphan Hydrobromide 10mg

PURPOSE

PURPOSE

Analgesic

Decongestant

Antihistamine

Antitussive

USER SAFETY WARNINGS

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.

WARNINGS AND PRECAUTIONS

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 USE

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

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

ASK 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 OUT OF REACH OF CHILDREN

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 INTERACTIONS

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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

WARNINGS

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.

INDICATIONS & USAGE

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

INGREDIENTS AND APPEARANCE

XL3 XTRA 
acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-440
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 1 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 1 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg  in 1 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	score with uneven pieces
Shape	CAPSULE (SOFT LIQUID FILLED CAPSULE)	Size	10mm
Flavor		Imprint Code	Xtra
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-440-01	20 mg in 1 BLISTER PACK; Type 0: Not a Combination Product	09/02/2015
2	NDC: 69772-440-02	12 mg in 1 BLISTER PACK; Type 0: Not a Combination Product	09/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/07/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
TERESA CECENA		078760958	relabel(69772-440)

Establishment
Name	Address	ID/FEI	Business Operations
Selder SA DE CV		824413629	manufacture(69772-440)