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NiteTime by PuraCap Pharmaceutical LLC

Medically reviewed on December 21, 2017

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-106

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.

NiteTime

Active Ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

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 daily while using this product

Sore throat warning: If sore throat is severe, lasts 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 phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with
  • smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an 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
  • 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, and tranquilizers may increase drowsiness

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.

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 for adults as well as 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 years of age and over swallow 2 softgels with water every 4 hours
 children 4 to under 12 years of age ask a doctor
 children under 4 years of age do not use
  • When using other Nighttime or Daytime products, carefully read each label to insure correct dosing

Other information
  • store at room temperature 15 o- 30 o C (59 o- 86 o F) 

Inactive Ingredients

D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Questions or comments?

Call toll free  1-855-215-8180

Product Labeling

MULTI-SYMPTOM

NiteTime Liquid Capsules

NDC 51013-106-01

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
pain reliever, fever reducer, cough suppressant,antihistamine

fever, headache, sore throat, coughing, minor aches and pains, runny nose and sneezing

Compare to the active ingredients in Vicks® NyQuil®*
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®


KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

NITETIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colorgreen (clear) Scoreno score
ShapeCAPSULE (oblong) Size21mm
FlavorImprint CodePC10
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-106-011 BLISTER PACK in 1 CARTON
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/26/201411/30/2018
Labeler - PuraCap Pharmaceutical LLC (962106329)
Registrant - Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-106), analysis(51013-106)

 
PuraCap Pharmaceutical LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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