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daytime nighttime by HyVee Inc

Dosage form: kit
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL; ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: HyVee Inc
NDC Code: 42507-912

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.

Hy-Vee, Inc. Daytime and Nighttime Cold & Flu Drug Facts

Active ingredient for Nighttime (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredient for Daytime (in each 15 mL tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if:

  • adult takes more than 4 doses in 24 hours (Nighttime) or more than 6 doses in 24 hours (Daytime), which is the maximum daily amount
  • child takes more than 5 doses in 24 hours (Daytime)
  • taken with other drugs containing acetaminophen
  • adult has 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.

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 sleepy

Ask a doctor before use if you have
  • high blood pressure (Daytime only)
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • trouble urinating due to an enlarged prostate gland
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma or emphysema
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)
  • a sodium-restricted diet (Nighttime only)

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

When using these products
  • do not use more than directed

In addition, when using Nighttime:

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless (Daytime only)
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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.

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 recommended – see Liver warning
  • take Nighttime or Daytime
  • use dose cup

Nighttime Liquid

  • do not exceed 4 doses per 24 hours
adults and children 12 years and over30 mL (2 TBSP) every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Daytime Liquid

  • do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
adults and children 12 years and over30 mL (2 TBSP) every 4 hours
children 6 to under 12 years15 mL (1 TBSP) every 4 hours
children 4 to under 6 yearsask a doctor
children under 4 yearsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
  • each TBSP of Nighttime contains: sodium 18 mg
  • each TBSP of Daytime contains: sodium 7 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavors, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

SEE NEW WARNINGS INFORMATION

Compare to Vicks® DayQuil® active ingredients

Daytime Cold & Flu

Non-Drowsy

Multi-Symptom Relief

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Phenylephrine HCl - Nasal Congestion

ALCOHOL FREE

ANTIHISTAMINE FREE

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

SEE NEW WARNINGS INFORMATION

Compare to Vicks® NyQuil® active ingredients

Nighttime Cold & Flu

Original Flavor

Multi-Symptom Relief

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Doxylamine succinate - Sneezing, Runny Nose

10% ALCOHOL

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Daytime and Nighttime Cold & Flu Carton Image 1

Daytime and Nighttime Cold & Flu Carton Image 2

Daytime and Nighttime Cold & Flu Carton Image 3

Daytime and Nighttime Cold & Flu Carton Image 4

Daytime and Nighttime Cold & Flu Carton Image 5

DAYTIME NIGHTTIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-912
Packaging
#Item CodePackage Description
1NDC:42507-912-011 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 296 mL
Part 21 BOTTLE 296 mL
Part 1 of 2
NIGHTTIME  COLD AND FLU
acetaminophen,dextromethorphan hbr, doxylamine succinate liquid
Product Information
Item Code (Source)NDC:42507-908
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 6 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorGREEN (Bright) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-908-38296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/27/2006
Part 2 of 2
DAY TIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Item Code (Source)NDC:42507-656
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
GLYCERIN 
MENTHOL 
SODIUM PHOSPHATE, MONOBASIC 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorORANGE (clear) Score    
ShapeSize
FlavorMENTHOL (with fruit) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-656-38296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/11/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/04/2006
Labeler - HyVee Inc (006925671)

Revised: 01/2012
 
HyVee Inc

← See all daytime nighttime brands

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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