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XL-3 Cold Medicine

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: A&Z Pharmaceutical, Inc.
NDC code: 62211-275

Drug Facts

Active ingredient

Acetaminophen
Chlorpheniramine maleate
Phenylephrine HCl

Purpose

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 8 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

Do Not Use

for more than 7 days 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 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 aretaking sedatives or tranquilizers

do not use more than directed excitability may occur, especially in children may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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 pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 daysYou may report side effects to 1-888-952-0050

If pregnant or breast-feeding

ask a health professional before use

Keep Out of Reach of Children

In case of overdose, contact a Poison Control Center 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 4 hours
Do not take more than 12 tablets in 24 hours
Children under 12 years of age: ask a doctor

Inactive Ingredients

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

Package/Label Principal Display Panel
XL-3  COLD MEDICINE
acetaminophen and chlorpheniramine maleate and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-275
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 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize11mm
FlavorImprint CodeAZ275
Contains    
Packaging
#Item CodePackage Description
1NDC:62211-275-2020 TABLET in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/11/2014
Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705ANALYSIS(62211-275), LABEL(62211-275), MANUFACTURE(62211-275), PACK(62211-275), RELABEL(62211-275), REPACK(62211-275)

Revised: 09/2014
 
A&Z Pharmaceutical, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.