FDA Label for Vicks Sinex Severe All In One Sinus
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH LIQUICAP)
- 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
- OTC - WHEN USING
- 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 - 24 LIQUICAP CARTON
Vicks Sinex Severe All In One Sinus Product Label
The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. 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
Made in Canada
DIST. BYPROCTER & GAMBLE,
CINCINNATI OH 45202
Active Ingredients (In Each Liquicap)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Nasal decongestant
Uses
temporarily relieves symptoms due to the common cold (or a cold)
- minor aches and pains
- headache
- fever
- nasal congestion
- sinus congestion & pressure
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies
- minor aches and pains
- headache
- nasal congestion
- sinus congestion & pressure
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
Otc - When Using
When using this product, do not use more than directed
Stop Use And Ask A Doctor If
- 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
- you get nervous, dizzy or sleepless
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
In case of overdose, get medical help or contact a Poison Control Center 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
- take only as directed
- do not exceed 8 LiquiCaps per 24 hrs
adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
Other Information
- do not exceed 25°C
Inactive Ingredients
FD&C Yellow No. 6, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution. *May contain this ingredient.
Questions?
1-800-873-8276
Principal Display Panel - 24 Liquicap Carton
VICKS®
Sinex ™
SEVERE
Acetaminophen - Pain Reliever/Fever Reducer,
Phenylephrine HCl - Nasal Decongestant
ALL IN ONE SINUS
- Sinus Pressure
- Sinus Headache & Pain
- Sinus Congestion
- Stuffy Nose
NON-DROWSY
24 LiquiCaps ™
* Please review the disclaimer below.