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Cold Medicine

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-275

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.

XL-3 Cold Medicine

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves:

■ minor aches and pains

■ headaches

■ nasal congestion

■ sinus congestion & pressure

■ runny nose

■ sneezing

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 maximum 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

■ if you are allergic to acetaminophen

■ more than 10 days unless directed by a doctor

■ 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

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ glaucoma

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you

■ are taking the blood thinning drug warfarin

■ are taking sedatives or tranquilizers

When using this product

■ do not use more than directed

■ excitability may occur, especially in children

■ may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ redness or swelling is present  

■ new symptoms occur  

■ you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days

■ fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

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

Keep out of reach of children.

Keep out of reach of children.  In case of overdose, contact a Poison Control Center (1-800-222-1222) immediately.

Prompt 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

■ Adults and children 12 years of age and older: take 2 tablets every 6 hours.  Do not take more than 12 tablets in 24 hours.

■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

■ store at room temperature in a dry place

■ do not use if blister package is torn.

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions and comments?

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Principal Display Panel

XL-3 Cold Medicine

 

COLD MEDICINE 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-275
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
HYPROMELLOSES 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAZ;275
Contains    
Packaging
#Item CodePackage Description
1NDC:63654-275-202 BLISTER PACK in 1 CARTON
110 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/15/2011
Labeler - Selder, S.A. de C.V. (824413629)

Revised: 01/2017
 
Selder, S.A. de C.V.

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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