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

Medically reviewed on August 22, 2017

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 250mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Selgel México, S.A. de C.V.
NDC Code: 58596-001

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
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg

Phenylepherine Hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Antitussive (cough suppressant)

Nasal decongestant

Uses

temporarily relieves: ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ runny nose ▪ sneezing ▪ itching of the nose or throat

▪ itchy, watery eyes due to hay fever or other upper respiratory allergies ▪ nasal congestion ▪ 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 ▪ for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor ▪if you are taking sedatives or tranquilizers, without first consulting your doctor.

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 ▪ difficulty in urination due enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

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 ▪ avoid alcoholic beverages

Stop use and ask a doctor if

▪ pain, nasal congestion or cough gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occur.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

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) ▪ do not use for more than 10 days unless directed by a doctor ▪ Adults and children 12 years of age and over ▪ take 2 capsule every 4 hours. ▪ do not take more than 12 capsules in 24 hours ▪ Children under 12 years of age ▪ do not use this adult product in children under 12 years of age; this will provide more than recommended dose (overdoes) and may cause liver damage.

Other Information

Store at room temperature in a dry place

Inactive Ingredients

DC red no. 33, FDC blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, water

Front 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:58596-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE ) PHENYLEPHRINE HYDROCHLORIDE5 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:58596-001-1212 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2014
Labeler - Selgel México, S.A. de C.V. (812296782)
Establishment
NameAddressID/FEIOperations
Selgel México, S.A. de C.V.812296782manufacture(58596-001)
Establishment
NameAddressID/FEIOperations
Progela, S.A. de C.V.812374932manufacture(58596-001)

 
Selgel México, S.A. de C.V.

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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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