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Daytime and Nighttime Cold and Flu

Medically reviewed on July 12, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-196

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.

Daytime and Nighttime Cold and Flu

Active ingredients (in each softgel)

Active ingredients for Nighttime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Daytime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

NIGHTTIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant 

Antihistamine

DAY TIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing (Nighttime only)
  • nasal congestion (Daytime only)

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

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

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 (Nighttime only)

Ask a doctor before use if you have
  • liver disease
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • high blood pressure (Daytime only)
  • 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
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers (Nighttime only)
  • taking the blood thinning drug warfarin

When using these products
  • do not use more than directed

In addition, when using Nighttime:

  • 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
  • you get nervous, dizzy, or sleepless (Daytime only)
  • pain, cough or nasal congestion (Daytime only) gets worse or last more than 7 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • 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 the recommended dose 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 for children even if you do not notice any signs or symptoms.

Directions
  • take only as directed - see Overdose warning
  • Take Nighttime or Daytime
  • do not exceed 4 doses per 24 hrs         
AgeDaytime Nighttime
 adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs
 children 4 to under 12 yrs ask a doctor ask a doctor
 children under 4 yrs do not usedo not use

  • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

Daytime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Nighttime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink 

Questions or comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Daytime and Nighttime Liquid Capsules 12ct 

NDC 51013-196-02

*Compare to the active ingredients in VICKS® DayQuil® and NyQuil® Cold and Flu LiquiCaps®

DAYTIME AND NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-196
Packaging
#Item CodePackage Description
1NDC:51013-196-021 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK
Part 1 of 2
DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
Colororange (clear) Scoreno score
Shapecapsule (oblong) Size20mm
FlavorImprint CodePC9
Contains    
Packaging
#Item CodePackage Description
11 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/12/2017
Part 2 of 2
NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
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 
SORBITAN 
Product Characteristics
Colorgreen (clear) Scoreno score
Shapecapsule (oblong) Size20mm
FlavorImprint CodePC10
Contains    
Packaging
#Item CodePackage Description
11 BLISTER PACK in 1 CARTON
14 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/12/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-196), analysis(51013-196)

 
PuraCap Pharmaceutical LLC

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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