Cold Medicine XL3 FORTE by Selder, S.A. de C.V.
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.
Acetaminophen 325 mg
Chlorpheniramine maleate 4 mg
Phenylepherine HCl 10 mg
Pain reliever/fever reducer
temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing
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
■ 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.
■ 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
■ are taking the blood thinning drug warfarin ■ are taking 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
■ 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
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.
■ 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.
■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged
Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive
You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST
|Labeler - Selder, S.A. de C.V. (824413629)|
|Selder, S.A. de C.V.||824413629||manufacture(63654-601)|
Medically reviewed on Oct 16, 2018