FDA Label for Sinus Congestion And Pain Daytime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH GELCAP)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sinus Congestion And Pain Daytime Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores 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.
Active Ingredients (In Each Gelcap)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Nasal decongestant
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- 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
Warnings
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- heart disease
- diabetes
- liver disease
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- 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 occur
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
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.
Directions
- 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
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
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
Questions Or Comments?
1-888-287-1915
Principal Display Panel
NDC 49035-558-22
equate™
Compare to
Tylenol® SINUS
+ HEADACHE
Day Active
Ingredients*
Rapid Release
Sinus
Congestion
& Pain
Acetaminophen, Phenylephrine HCl
Pain Reliever, Fever Reducer, Nasal Decongestant
Daytime Non-Drowsy
• Sinus headache & pressure
• Nasal congestion
48 GELCAPS
Actual Size
TAMPER EVIDENT:
DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS
TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERING
Satisfaction guaranteed -
Or we'll replace it or give you your
money back.
For questions or comments,
please call 1-888-287-1915.
DISTRIBUTED BY: Wal-Mart, Inc.,
Bentonville, AR 72716
*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Tylenol®
SINUS + HEADACHE Day.
50844 REV0216A55822
* Please review the disclaimer below.