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Name:Night Time Gelcap
Manufacturer:Kareway Product, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NIGHT TIME GELCAP  - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled 
Kareway Product, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Enter section text here

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

Enter section text here

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

Enter section text here

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

nighttime image of carton


NIGHT TIME GELCAP 
acetaminophen, dextromethorphan, doxylamine capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0521
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
GELATIN  
GLYCERIN  
POLYETHYLENE GLYCOL  
POVIDONE  
PROPYLENE GLYCOL, (R)-  
WATER  
SORBITOL  
Product Characteristics
Color green Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code NYTIME
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67510-0521-1 1 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK
1 10 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the BOX (67510-0521-1)
2 NDC:67510-0521-2 1 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK
2 12 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the BOX (67510-0521-2)
3 NDC:67510-0521-0 2 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK
3 20 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the BOX (67510-0521-0)
4 NDC:67510-0521-4 2 BLISTER PACK ( BAG) in 1 BOX contains a BLISTER PACK
4 24 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the BOX (67510-0521-4)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/01/2011

Labeler - Kareway Product, Inc. (121840057)

Revised: 05/2011 Kareway Product, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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