FDA Label for Xpect Cold Relief
View Indications, Usage & Precautions
Xpect Cold Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cintas Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Purpose
Active ingredients (in each tablet)
Acetaminophen 325mg……………..Internal Analgesic
Guaifenesin 200mg……………………...Expectorant
Phenylephrine HCl 5mg……………Nasal decongestant
Uses
Temporarily:
• Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Relieves sinus congestion and pressure, helps decongest sinus openings and passages
• Restores free breathing
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes and make coughs more productive
Temporarily relieves minor aches, pains, and fever associated with:
• Headache
• Common cold
• Toothache
• Backache
• Muscular aches
• Menstrual cramps
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• More than 8 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 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 pharmacists before using this product.
• With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask doctor or pharmacist before use if you are taking the blood thinner, warfarin.
When using this product do not exceed recommended dose.
Stop use and ask doctor if:
• Nervousness, dizziness, or sleeplessness occurs
• Symptoms do not improve within 7 days or are accompanied by fever
• Pain or fever persists or gets worse
• New symptoms occur
• Redness or swelling is present
• Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
Ask a doctor before use if you have:
• Liver disease
• Heart disease
• High blood pressure
• Thyroid disease
• Difficulty in urination due to enlargement of the prostate gland
• Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus)
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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
• Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not exceed 8 tablets in 24 hours, or as directed by a doctor.
• Children under 12 years: Consult a doctor
Other Information
• Do not use if packet is torn, cut or opened
• Store at controlled room temperature 15 to 30C (59 to 86F)
• Avoid excessive heat and humidity
* Please review the disclaimer below.