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NightTime Sinus Relief (acetaminophen 325 mg doxylamine succinate 6.25 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Antihistamine
  3. Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Generic: acetaminophen, doxylamine succinate, phenylephrine hydrochloride is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

NightTime Sinus Relief solution - (acetaminophen 325 mg doxylamine succinate 6.25 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: PC13     SHAPE: capsule
    COLOR: blue

  1. FDA Adverse Reactions

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Active Ingredients (in Each Capsule)


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 

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

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, Hubei430206, China

Principal Display Panel - Shipping Label


NightTime Sinus Relief Capsules

Quantity : 4000 CapsulesNDC. 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"



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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