MULTI-SYMPTOM NIGHTTIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
PuraVation Pharmaceuticals Inc
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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Active ingredients (in each softgel)
Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever
Antihistamine
Nasal decongestant
Uses
temporarily relieves nasal & sinus symptoms:
- sinus pain
- headache
- nasal & sinus congestion
-
runny nose & sneezing
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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hrs
Adults & children 12 yrs & over
| 2 softgels with water every 4 hrs |
Children 4 to under 12 yrs
| ask a doctor |
children under 4 yrs
| do not use |
-
when using other NIGHTTIME or DAYTIME products, carefully read each label to insure correct dosing
Other information
- store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide
PRINCIPAL DISPLAY PANEL - 20 Softgels Carton
Sinus Relief NIGHTTIME
NDC 76270-114-08
*Compare to the active ingredients in VICKS®NYQUIL®SINEX®
Acetaminophen
Pain Reliever
Doxylamine Succinate
Antihistamine
Phenylephrine
Nasal Decongestant
Relieves:
- Sinus Headache and Pain
- Runny Nose
- Sinus Congestion and Pressure
SEE NEW WARNINGS INFORMATION
20 softgels