Night Time Gelcap

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, DOXYLAMINE SUCCINATE 5mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0521

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.

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

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

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

Pure-Aid Nighttime Gelcap

NIGHT TIME GELCAP 
acetaminophen, dextromethorphan, doxylamine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0521
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POVIDONE 
PROPYLENE GLYCOL, (R)- 
WATER 
SORBITOL 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize24mm
FlavorImprint CodeNYTIME
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0521-11 BLISTER PACK (BLISTER PACK) in 1 BOX
110 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
2NDC:67510-0521-21 BLISTER PACK (BLISTER PACK) in 1 BOX
212 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
3NDC:67510-0521-02 BLISTER PACK (BLISTER PACK) in 1 BOX
320 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
4NDC:67510-0521-42 BLISTER PACK (BAG) in 1 BOX
424 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 05/2011
 
Kareway Product, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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