FDA Label for Cold And Sinus Pain Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET) .........................................PURPOSE
- USES:
- LIVER WARNING:
- ALLERGY WARNING:
- DO NOT USE:
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF:
- STOP USE AND ASK A DOCTOR IF:
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- IF PREGNANT OR BREAST-FEEDING BABY,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION
- INACTIVE INGREDIENTS:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cold And Sinus Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Redicare Llc. 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.
Active Ingredients (In Each Tablet) .........................................Purpose
Acetaminophen 325 mg ........................................................................................................pain reliever/fever reducer
Guaifenesin 200 mg .....................................................................................................................................expectorant
Phenylephrine HCI 5 mg ...........................................................................................................................decongestant
Uses:
temporarily: ■ relieves nasal congestion associated with sinusitis ■ 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 freer 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
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.
Allergy Warning:
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:
■ with any other product containing acetaminophen; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ when using this product do not exceed recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.
Ask A Doctor Or Pharmacist Before Use If:
■ you are taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If:
■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by a fever • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
Ask A Doctor Before Use If You Have:
■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ 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 Baby,
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 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
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity
Inactive Ingredients:
FD&C Red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid
* Please review the disclaimer below.