FDA Label for Pain And Sinus Reliever
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USE
- LIVER WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 250 TABLET PACKET BOX
Pain And Sinus Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Jhk Dba American Safety & First Aid. 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
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 - Purpose
Active ingredient (In Each Tablet) | Purpose |
---|---|
Acetaminophen 500 mg | pain reliever/fever reducer |
Phenylephrine 5 mg | nasal decongestant |
Use
temporarily relieves:
- headache
- sinus pain
- nasal and sinus congestion
- minor aches and pains
- fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 tablets or 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen (prescription or nonprescription)
- 3 or more alcoholic drinks every day while using this product
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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product
- for more than 3 days for fever unless directed by a doctor
- with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist
- for more than 10 days for pain unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland.
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you are taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
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.
Overdose Warning
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 6 hours
- do not exceed 8 tablets in 24 hours
Children under 12 years of age: Ask a doctor
Other Information
- store at room temperature between 20-25 °C (68-77° F)
- do not use if packet is opened or torn
Inactive Ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
Questions?
1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
Principal Display Panel - 250 Tablet Packet Box
Product #1194
Pain & Sinus
Reliever
Active ingredient:
Acetaminophen
Phenylephrine
Pain Reliever/Nasal Decongestant
- Formulated for relief from sinus pressure
and nasal congestion - Aspirin free non-drowsy formula
These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2021 standards.
They are sealed in tamper evident packets for safety and convenience.
250 Tablets • 2 Tablets Per Packet
* Please review the disclaimer below.