FDA Label for Mckesson Sinus Pain And Pressure Relief
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Mckesson Sinus Pain And Pressure Relief Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson Medical-surgical. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each tablet)
Acetaminophen 500mg
Phenylephrine HCl 5mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Nasal decongestant
Indications & Usage
Uses
temporarily relieves these common cold/flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- stuffy nose
- sinus congestion and pressure
temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
Otc - Do Not Use
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- for more than 10 days unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dosage.
Otc - Stop Use
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms appear
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Over dose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
- do not use more than directed
Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
Children under 12 years: Ask a doctor
Other Safety Information
Other information
- store at room temperature 59°-86°F (15°-30°C)
- tamper evident sealed packets
- do not use any opened or torn packets
- avoid excessive heat and humidity
Inactive Ingredient
Inactive imgredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.
Otc - Questions
Questions or comments? C all 1-800-777-4908
Package Label.Principal Display Panel
McKesson
Sinus Pain and Pressure Relief
Acetaminophen 500 mg | Phenylephrine HCl 5 mg
NDC 68599-4751-3
This Package is for Households without Young Children.
Non-aspirin pain relief and pseudoephrine-free sinus decongestant.
* Please review the disclaimer below.