FDA Label for Pain And Sinus Reliever
View Indications, Usage & Precautions
Pain And Sinus Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Advanced First Aid, Inc.. 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.
Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET-
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
Otc - Purpose
pain reliever/fever reducer
decongestant
Indications & Usage
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
temporarily relieves minor aches, pains, and fever associated with: • headache • common cold • toothache • backache • muscular aches • menstrual cramps
Warnings
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 • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product
Alergy 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:
• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
• more than the recommended dose
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this prouct.
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 fever
Ask a doctor before use if you have: • heart disease • liver disease •high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
When using this product do not exceed recommended dose.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: Consult a doctor.
Inactive Ingredient
Inactive Ingredients: FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid.
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