Cold Medicine

FDA Drug Profile — Cold Medicine

Drug Details

Generic Name
Cold Medicine
Brand Names
Cold Medicine
Application Number
M012
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Use(s) temporarily relieves minor aches and pains headaches nasal congestion sinus congestion & pressure runny nose sneezing

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 10 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 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 Pregnancy/Breastfeeding 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.