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DayTime Nighttime multi symptom cold and flu relief

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Shopko Stores Operating Co., LLC.
NDC Code: 37012-490

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 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

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:

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

Warnings

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

  • more than 4 doses in 24 hours, 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, 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 (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 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)
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or occurs with fever, 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 and for children even if you do not notice any signs or symptoms

Directions
  • take only as directed – see overdose warning
  • take Nighttime OR Daytime

Nighttime Softgels

  • do not exceed 4 doses per 24 hours
 adults and children 12 years and over swallow 2 softgels with water every 6 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use

Daytime Softgels

  • do not exceed 4 doses per 24 hours
 adults and children 12 years and over swallow 2 softgels with water every 4 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

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

Inactive ingredients

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

Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white printing ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, and sorbitol

*may contain this ingredient

Questions or comments?

call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

**Compare to Vicks® Nyquil® and Vicks® Dayquil® active ingredients

**These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® and Vicks® Dayquil®

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.

Packaged by: PL Developments

200 Hicks street Westbury

NY 11590, USA

Product Label

daytime nighttime cold and flu relief

DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-490
Packaging
#Item CodePackage Description
1NDC:37012-490-481 KIT (1 KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 24 BLISTER PACK 32 
Part 1 of 2
NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule
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 
SORBITAN 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize21mm
FlavorImprint CodeP30;94A;35A
Contains    
Packaging
#Item CodePackage Description
18 CAPSULE (8 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart341
Part 2 of 2
DAYTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeP19;95A;36A
Contains    
Packaging
#Item CodePackage Description
18 CAPSULE (8 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/10/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/10/2012
Labeler - Shopko Stores Operating Co., LLC. (023252638)

Revised: 08/2012
 
Shopko Stores Operating Co., LLC.

← See all DayTime Nighttime multi symptom cold and flu relief 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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