Cold MedicineXL3
- Dosage form
- TABLET
- Labeler
- Selder, S.A. de C.V.
- Label updated
- 2024-10-17
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · CHLORPHENIRAMINE MALEATE · PHENYLEPHRINE HYDROCHLORIDE
Active ingredients (in each tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylepherine 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
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 ■ 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 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 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. In case of overdose, get medical help or 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 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) 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
alcohol, croscarmellose sodium, hypromellose, lactose monhydrate (derived from milk), magnesium stearate, polyethylene glycol, purified water, talc, titanium dioxide
Questions and Comments?
1-855-259-1590 Monday through Friday 9AM-5PM EST
Package Label
[Image in the official label — see DailyMed source]
DailyMed Set ID: e2c35fae-9dd6-51f2-e053-2995a90a1e9e · Version 2
NDC: 63654-605