Vicks ® Sinex™ Daytime Congestion, Pressure & Pain and Nighttime Congestion, Pressure & Pain
Drug Labeling and Warnings
Drug Details [pdf]
SINEX- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate
The Procter & Gamble Manufacturing Company
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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Vicks
® Sinex™
Daytime Congestion, Pressure & Pain and Nighttime Congestion, Pressure & Pain
Uses
- temporarily relieves symptoms due to the common 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
Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
Directions
- take only as directed
- do not exceed 4 doses 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 |
Inactive ingredients
FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Uses
- temporarily relieves symptoms due to the common cold
- minor aches and pains
- headache
- fever
- runny nose and sneezing
- nasal congestion
- sinus congestion & pressure
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies
- minor aches and pains
- headache
- runny nose and sneezing
- itching of the nose or throat, and itchy, watery eyes
- nasal congestion
- sinus congestion & pressure
Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- to make a child sleep
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives & tranquilizers may increase drowsiness
Directions
- take only as directed
- do not exceed 4 doses 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 |
Inactive ingredients
FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
PRINCIPAL DISPLAY PANEL - Kit Carton
FAST
RELIEF
VICKS®
Sinex™
DAYTIME CONGESTION,
PRESSURE & PAIN
Acetaminophen-Pain Reliever;
Phenylephrine HCl-Nasal Decongestant
- Sinus Congestion & Pressure
- Pain & Headache
Non-Drowsy
32 DAYTIME LIQUICAPS ®
Sinex™
NIGHTTIME CONGESTION,
PRESSURE & PAIN
Acetaminophen-Pain Reliever;Doxylamine succinate-
Antihistamine; Phenylephrine HCl-Nasal Decongestant
- Sinus Congestion & Pressure
- Pain & Headache
16 NIGHTTIME LIQUICAPS ® 48 TOTAL
| SINEX
acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit |
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| Labeler - The Procter & Gamble Manufacturing Company (004238200) |
Revised: 7/2019
Document Id: 8d6ad0dd-ad47-2f56-e053-2a95a90a3d3f
Set id: 3a359176-1d69-3851-e054-00144ff8d46c
Version: 3
Effective Time: 20190711
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