Night Time Sinus And Congestion
FDA Label NDC 68016-733

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Night Time Sinus And Congestion (NDC 68016-733). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use ifyou are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Antihistamine

Nasal decongestion

Uses

  • temporarily relieves symptoms due to common cold
  • minor aches and pains
  • headache
  • fever
  • runny nose and sneezing  
  • nasal congestion
  • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
  • minor aches and pains
  • headache
  • runny nose and sneezing
  • itching of the nose or throat, and itchy, watery eyes
  • nasal congestion
  • sinus congestion & pressure

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 for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use Ifyou 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 Doctor If

  • pain or nasal congestion 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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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
  • take only as directed

    • adults & children 12 years & over

    		2 Liquid Caps with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

Other Information

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

Inactive Ingredients

edible white ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol

Questions Or Comments?

1-800-706-5575

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Premier Value

Nighttime Sinus and Congestion

NDC number 68016-733-16

16 Liquid Capsule

Sinus-congestion-nighttime-16count-ctn (P104375 Aceta Phep Doxl Sgcp Ctn 16 Cdc)

Sinus-congestion-nighttime-16count-ctn (P104375 Aceta Phep Doxl Sgcp Ctn 16 Cdc)

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