Night Time Gelcap
FDA Label NDC 67510-0521

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Night Time Gelcap (NDC 67510-0521). 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 ingredients(in each gelcap), purpose, uses, warnings, liver warning, sore throat warning:, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients(In Each Gelcap)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

Liver Warning

This product contains acetaminophen.  Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore Throat Warning:

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

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
  • glaucoma
  • cough that occurs with too much phegm(mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • 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

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Stop Use And Ask A Doctor If

  • pain or cough 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
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

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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 to adults and 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 and children 12 yrs and over
    		2 GelCaps with water every 6 hrs
    children 4 to under 12 yrs
    		ask a doctor
    children under 4 yrs
    		do not use

Other Information

  • store at room temperature

Inactive Ingredients

FDC yellow no. 5, dioxide, FDC blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special

Package Label.Principal Display Panel

Pure-Aid Nighttime Gelcap

Image Of Carton (Nighttime.carton2)

Image Of Carton (Nighttime.carton2)

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