FDA Label for Sinus Head Congestion
View Indications, Usage & Precautions
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sinus Head Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Vivunt Pharma Llc. 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.
Purpose
Active ingredients (in each softgel) | Purpose |
Acetaminophen 325 mg | Pain Reliever-Fever reducer |
Phenylephrine HCl 5 mg | Nasal Descongestant |
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 respiratory allergies
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 Softgels 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
- skin reddening
- blisters
- rash.
- If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay include:
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, psyciatric 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 Or Pharmacist Before Use If You Are
Taking the blood thinning drug warfarin.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- hight blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
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
Keep Out Of Reach Of Children
Keep out of reach of children
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 (see overdose warning)
- do not exceed 8 softgels per 24 hrs
adults and children 12 years and over | 2 softgels with water every 4 hours |
children 4 to under 12 years | consult a doctor |
children under 4 years | do not use |
Other Information
Do not exceed 25°C
TAMPER EVIDENT:This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
Inactive Ingredients
FD&C yellow no.6, Gelatin, Glycerin, Methylparaben, Polyethylene glycol 400, Povidone K 30, Propylene glycol, Propyparaben, Purified water, Sorbitol, Titanium Dioxide.
Package Label.Principal Display Panel
Compare to Vicks® Sinex TM
Severe All in One Sinus TM
Liquicaps®
active ingredients*
NDC 82706-025-01
Sinus
HEAD CONGESTION
PRESSURE & PAIN
-Sinus Pressure
-Sinus Headache & Pain
-Sinus Cingestion
-Stuffy Nose
NON-DROWSY
Acetaminophen
Phenylephrine HCl
24 SOFTGELS**
**Liquid-filled capsules
*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® Sinex TM All in One Sinus TM LiquiCaps ®.
Lic. No. :"DD/DRUGS/DD/416"
VIVUNT TM
Distributed by: VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, FL 33156-3178. Made in India.
www.vivunt.live
* Please review the disclaimer below.