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Cold Medicine XL3 FORTE by Selder, S.A. de C.V.

Medically reviewed on February 6, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 4mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-601

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 tablet)

Acetaminophen 325 mg
Chlorpheniramine maleate 4 mg
Phenylepherine HCl 10 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 6 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

Alergy 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 ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins 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 adoctor before use if you have

■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to 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 ■ 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 days

Keep out of reach of children

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 (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) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Other Information

■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged

Inactive Ingredients

Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

Questions and Comments?

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

Package Label

COLD MEDICINE  XL3 FORTE
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-601
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
TRIACETIN 
LACTOSE MONOHYDRATE 
STEARIC ACID 
POVIDONE 
HYPROMELLOSES 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 5 
WATER 
ALCOHOL 
Product Characteristics
Coloryellow (light yellow) Scoreno score
ShapeROUND (Tablet) Size5mm
FlavorImprint CodeXL3;FORTE
Contains    
Packaging
#Item CodePackage Description
1NDC:63654-601-5050 PACKET in 1 BOX
1NDC:63654-601-044 TABLET in 1 PACKET
2NDC:63654-601-202 BLISTER PACK in 1 BOX
210 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2017
Labeler - Selder, S.A. de C.V. (824413629)
Establishment
NameAddressID/FEIOperations
Selder, S.A. de C.V.824413629manufacture(63654-601)

 
Selder, S.A. de C.V.

← See all Cold Medicine XL3 FORTE brands

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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