FDA Label for Daytime Sinus Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH SOFTGEL)
- PURPOSES
- 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
- PRODUCT LABEL
Daytime Sinus Relief Product Label
The following document was submitted to the FDA by the labeler of this product Assured / Dollar Tree (greenbrier International, 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 Softgel)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Purposes
Pain reliever
Nasal decongestant
Uses
temporarily relieves sinus symptoms:
- sinus pain
- headache
- nasal and sinus congestion
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 any 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
- thyroid disease
- diabetes
- high blood pressure
- difficulty in urinating due to an enlarged prostate gland
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
- redness or swelling is present
- you get nervous, dizzy, or sleepless
- fever gets worse or lasts more than 3 days
- new symptoms occur
- symptoms do not get better within 7 days or are accompanied by a fever
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Keep Out Of Reach Of Children.
Overdose warning: Taking more than the recommended dose could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see Overdose warning)
- do not exceed 4 doses in 24 hours
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
adults and children 12 years of age and over | take 2 softgels with water every 4 hours |
children 4 to under 12 years of age | ask a doctor |
children under 4 years of age | do not use |
Other Information
- store at room temperature 15o - 30o C (59o- 86o F) and avoid excessive heat
Inactive Ingredients
FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, edible white ink.
Questions Or Comments?
call 1-877-753-3935 Monday- Friday 9AM- 5PM EST
Principal Display Panel
Compare to active ingredients in Vicks® Dayquil® Sinex® LiquiCaps® *
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Dayquil® Sinex® LiquiCaps®
DAYTIME
Sinus Relief
Liquid Capsules
Non- drowsy
Acetaminophen- Sinus Headache and Pain
Phenylephrine HCl- Sinus Pressure and Congestion
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by:
Greenbrier International, INC.
500 Volvo parkway, Chesapeake, VA 23320
PRODUCT OF CANADA
**Product may vary from image shown
Product Label
Daytime sinus relief liquid capsules
* Please review the disclaimer below.