Cold Medicine ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHRINE HCL SELDER, S.A. DE C.V. FDA Approved Uses temporarily relieves: ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■ sneezing
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients corn starch crospovidone hypromellose microcrystalline cellulose polyethylene glycol povidone pregelatinized starch stearic acid
Strengths
325 mg 2 mg 5 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Headaches Nasal Congestion Sinus Congestion Pressure Runny Nose Sneezing
Pill Appearance
Shape: round Color: white Imprint: AZ;275

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D V1Q0O9OJ9Z 04JA59TNSJ
Packaging

Principal Display Panel XL-3 Cold Medicine XL-3 Cold Medicine

Package Descriptions
  • Principal Display Panel XL-3 Cold Medicine XL-3 Cold Medicine

Overview

Uses temporarily relieves: ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■ sneezing

Indications & Usage

Uses temporarily relieves: ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■ sneezing

Dosage & Administration

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.

Warnings & Precautions
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.
Purpose

Purposes Pain reliever/fever reducer Antihistamine Nasal decongestant

Do Not Use

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.

When Using

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 & Ask a Doctor

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

Keep Out of Reach of Children

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.

Questions

Questions and comments? 1-888-952-0050 Monday through Friday 9 AM - 5 PM EST


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