Cold Medicine
Cold Medicine is an FDA drug label for the active ingredient COLD MEDICINE manufactured by Allegiant Health administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211123.
- Generic name
- COLD MEDICINE
- Manufacturer
- Allegiant Health
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69168-004
- Application
- M012
- Label effective
- 20211123
Active ingredients
Indications & Usage
Use(s) 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 4 to 6 hours Do not take more than 10 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.
Contraindications
Not available.
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.
Adverse Reactions
Not available.