Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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COUGH AND COLD XL3 XTRA- acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled 
Progela, 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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Drug Facts

Active ingredients (in each capsule)

Acetaminophen 250 mg

Chlorpheniramine Maleate 2 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Antitussive

Nasal decongestant

Uses

temporarily relieves: muscular 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 pressure 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 tablets in 24 hours, which is the máximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening blisters rash

if a skin reaction occurs, stop use and seek medical help right away.

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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 glaucoma heart disease high blood pressure thyroid disease diabetes difficulty in urination due to 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 alcohlic beverages

Stop use and ask a doctor if

symptoms do not improve pain, nasal congestion or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition nervousness, dizziness, or sleeplessness occur fever gets worse or lasts for more than 3 days.

Keep out of reach of children

If pregnant or breast-feeding, ask a health professional before use .

Keep out of the 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 (1-800-222-1222) 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 use more than directed (see overdose warning) do not take this product form 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 the recommended dose (overdoes) may cause liver damage. Do not exceed recommedned dosage

Other information

Store at room temperature to 15º-30ºC (59º-86ºF) do not use if package is torn or damaged

Inactive ingredients

D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water

Questions and Comments?

You may report any side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST

Package Label

package 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: 28623-250
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) PHENYLEPHRINE HYDROCHLORIDE5 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 (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
Colorblue (Sky Blue) Scoreno score
ShapeCAPSULE (Soft liquid filled capsule) Size10mm
FlavorImprint Code Xtra
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 28623-250-0120 in 1 BLISTER PACK; Type 0: Not a Combination Product03/01/201310/15/2018
2NDC: 28623-250-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product08/22/2014
3NDC: 28623-250-066 in 1 BLISTER PACK; Type 0: Not a Combination Product10/15/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2013
Labeler - Progela, S.A. de C.V. (812374932)
Establishment
NameAddressID/FEIBusiness Operations
Progela, S.A. de C.V.812374932manufacture(28623-250)

Revised: 10/2018
 
Progela, S.A. de C.V.


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