PAIN AND SINUS RELIEVER by ADVANCED FIRST AID, INC. / ULTRA SEAL CORPORATION / ULTRA TAB LABORATORIES, INC.
PAIN AND SINUS RELIEVER by
Drug Labeling and Warnings
PAIN AND SINUS RELIEVER by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PAIN AND SINUS RELIEVER- acetaminophen and phenylephrine tablet
ADVANCED FIRST AID, INC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 free breathing
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 you take with other drugs containing acetaminophen (prescription or non-prescription) you have 3 or more alcoholic drinks every day while using this product
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.
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 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.
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 or as needed, do not exceed 8 tablets
in 24 hours, or asdirected by a doctor.
Children under 12 years: Consult a doctor.
| PAIN AND SINUS RELIEVER
acetaminophen and phenylephrine tablet |
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| Labeler - ADVANCED FIRST AID, INC. (114477180) |
| Registrant - ADVANCED FIRST AID, INC. (114477180) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ULTRA SEAL CORPORATION | 085752004 | pack(67060-140) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ULTRA TAB LABORATORIES, INC. | 151051757 | manufacture(67060-140) | |