XL-3 XTRA- acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate, dextromethorphan hydrobromide capsule, liquid filled 
Promotora De Productos Mexicanos, 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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XL-3* Xtra

Drug Facts

Active Ingredients (in each capsule)

Acetaminophen 250 mg

Phenylephrine HCL 5 mg

Chlorpheniramine Maleate 2 mg

Dextromethorphan HBr 10 mg

Purpose

Pain Reliever/Fever Reducer

Nasal Decongestant

Antihistamine

Cough Suppressant

Uses

•For temporarily relieve •muscular aches •headache • fever •runny nose •sneezing •itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies •nasal congestion •temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings

Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take •more than 12 capsules in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this product
Do not exceed recommended dosage

DO NOT USE

•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. •if you are allergic to acetaminophen or any of the inactive ingredients in this product •in excess of recommended dosage • if you are now 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

Ask a doctor before use if you have •liver disease •a breathing problem such as emphysema or chronic bronchitis •glaucoma •heart disease• high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •a cough that lasts or is chronic such as occurs with asthma •a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are •taking the blood thinning drug warfarin •taking sedatives or tranquilizers

Stop use and ask doctor When using this product •excitability may occur, especially in children •may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect •use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if •pain gets worse or lasts more than 10 days •fever gets worse or lasts more than 3 days •new symptoms occur •redness or swelling is present •nervousness, dizziness, or sleeplessness occur •symptoms persists for more than 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN, If pregnant or breast-feeding, ask a health professional before use. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

* Do not take more than directed (see overdose warning) Adults and children under 12 years of age •do not take more than directed (see overdose warning) •take 2 capsule every 4 hours. •do not take more than 12 capsules in 24 hours •do not use for more than 10 days unless directed by a doctor under 12 years of age •ask a doctor

Inactive ingredients

FD&C Red 33, FD&C Blue 1, Gelatin, Glycerin, Polyethylene Glycol 600, Polyethylene Glycol 1000, Povidone, Propylene Glycol, Water

​Gripa y Tos Capsules

Tos

Fiebre

Cuerpo Cortado

Congestion Nasal

Escurrimiento Nasal

Packaging

image description

XL-3 XTRA 
acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate, dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72365-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapecapsuleSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72365-011-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product08/01/201812/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/201812/14/2018
Labeler - Promotora De Productos Mexicanos, S.a. De C.v. (814732467)

Revised: 12/2018
 
Promotora De Productos Mexicanos, S.a. De C.v.