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

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DayTime Sinus Relief

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

DayTime Sinus Relief capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each capsule)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

DayTime Sinus Relief Uses

temporarily relieves sinus symptoms:

  • sinus pain
  • headache
  • nasal & 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
  • 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.                                                                                                             

Ask a doctor before use if you have

  • liver disease       
  • heart disease              
  • thyroid disease
  • diabetes   
  • high blood pressure   
  • trouble urinating due to 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 use more than directed.

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 hours

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

DayTime Sinus Relief Other information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C Yellow #6, 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

DayTime Sinus Relief Capsules

Quantity : 4000 Capsules
NDC. No : 53345-012-01

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"

DayTime Sinus Relief

DayTime Sinus Relief

acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53345-012
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
povidone
propylene glycol
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
orange 21 mm PC12 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4000 in 1 BAG
2 NDC:53345-012-01 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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