Sinus Congestion and Pain Non-Drowsy
Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-558
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.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- helps decongest sinus openings and passages
- promotes sinus drainage
- helps clear nasal passages
- temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 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
if a skin reaction occurs, stop use and seek medical help right away.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- thyroid disease
- heart disease
- liver disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse of lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 10 gelcaps in 24 hours
- children under 12 years: ask a doctor
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide
CONGESTION & PAIN
Acetaminophen - Pain Reliever/Fever Reducer
Phenylephrine HCl - Nasal Decongestant
- Nasal Congestion
- Sinus Congestion & Pressure
24 RAPID RELEASE
Compare to the active ingredients in: Tylenol® SINUS + HEADACHE Day*
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS + HEADACHE Day.
|SINUS CONGESTION AND PAIN
acetaminophen and phenylephrine hcl tablet
|Labeler - FRED'S, INC. (005866116)|
|LNK International, Inc.||038154464||PACK(55315-558)|
|LNK International, Inc.||832867894||MANUFACTURE(55315-558)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.