FDA Label for Tylenol Sinus Severe
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- 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?
- PRODUCT DISTRIBUTED BY: JOHNSON & JOHNSON CONSUMER INC. MCNEIL CONSUMER HEALTHCARE DIVISION, FORT WASHINGTON, PA 19034 USA
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL 25CT BOX
- PRINCIPAL DISPLAY PANEL 30CT BOX
Tylenol Sinus Severe Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, 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.
Drug Facts
Drug Facts
Purpose
Active ingredients (in each caplet) | Purpose |
Acetaminophen 325 mg | Pain reliever/fever reducer |
Guaifenesin 200 mg | Expectorant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- nasal congestion
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
sinus congestion and pressure
Liver Warning
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
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.
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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When using this product do not exceed recommended dose
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough 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
- cough comes back or occurs with rash or headache that lasts
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.
Overdose 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.
Directions
do not take more than directed (see OVERDOSE WARNING)
adults and children 12 years and over |
|
children under 12 years | ask a doctor |
Other Information
- each caplet contains: sodium 3 mg
- store between 20-25°C (68-77°F)
- do not use if pouch is torn or damaged
Inactive Ingredients
carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Product Distributed By: Johnson & Johnson Consumer Inc. Mcneil Consumer Healthcare Division, Fort Washington, Pa 19034 Usa
Product distributed by: JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA
Repackaged and distributed by: Convenience Valet ®, Glendale Heights, IL 60139
Principal Display Panel
TYLENOL ®
FOR ADULTS
SINUS SEVERE
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant
SINUS HEADACHE
SINUS PRESSURE
NASAL CONGESTION
MUCUS + CHEST CONGESTION
DAY
NON-DROWSY
2 POUCHES OF 2 CAPLETS EACH
Principal Display Panel 25Ct Box
TYLENOL ®
FOR ADULTS
SINUS SEVERE
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant
SINUS HEADACHE
SINUS PRESSURE
NASAL CONGESTION
MUCUS + CHEST CONGESTION
DAY
NON-DROWSY
25 POUCHES OF 2 CAPLETS EACH
Principal Display Panel 30Ct Box
TYLENOL ®
FOR ADULTS
SINUS SEVERE
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant
SINUS HEADACHE
SINUS PRESSURE
NASAL CONGESTION
MUCUS + CHEST CONGESTION
DAY
NON-DROWSY
30 POUCHES OF 2 CAPLETS EACH
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