NDC 67510-0521 Night Time Gelcap

NDC Product Code 67510-0521

NDC CODE: 67510-0521

Proprietary Name: Night Time Gelcap What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
GREEN (C48329)
Shape: CAPSULE (C48336)
Size(s):
24 MM
Imprint(s):
NYTIME
Score: 1

NDC Code Structure

NDC 67510-0521-0

Package Description: 2 BLISTER PACK in 1 BOX > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 67510-0521-1

Package Description: 1 BLISTER PACK in 1 BOX > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 67510-0521-2

Package Description: 1 BLISTER PACK in 1 BOX > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 67510-0521-4

Package Description: 2 BLISTER PACK in 1 BOX > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Night Time Gelcap with NDC 67510-0521 is a product labeled by Kareway Product, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1112865.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kareway Product, Inc.
Labeler Code: 67510
Start Marketing Date: 06-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]

* Please review the disclaimer below.

Night Time Gelcap Product Label Images

Night Time Gelcap Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients(In Each Gelcap)

Acetaminophen 325mgDextromethorphan HBr 15mgDoxylamine succinate 6.25mg

Purpose

Pain reliever/fever reducerCough suppressantAntihistamine

Uses

  • Temporarily relieves common cold/flu symptoms:cough due to minor throat and bronchial irritationsore throatheadacheminor aches and painsfeverrunny nose and sneezing

Liver Warning

  • This product contains acetaminophen.  Severe liver damage may occur if you takemore than 4 doses in 24 hrs, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 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 diseaseglaucomacough that occurs with too much phegm(mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysematrouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizerstaking 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 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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 warningdo not exceed 4 doses per 24 hoursadults and children 12 yrs and over2 GelCaps with water every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo 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

* Please review the disclaimer below.