NightTime Sinus Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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NightTime Sinus Relief

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

NightTime Sinus Relief capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each capsule)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

NightTime Sinus Relief 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 taking NIGHTTIME and DAYTIME products, carefully read each label to insure correct dosing

NightTime Sinus Relief 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

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

NightTime Sinus Relief Capsules

Quantity : 4000 Capsules
NDC. No : 53345-013-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

NightTime Sinus Relief

NightTime Sinus Relief

Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53345-013
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
povidone
propylene glycol
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
blue 21 mm PC13 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4000 in 1 BAG
2 NDC:53345-013-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-06-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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