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daytime nitetime cold and flu by Meijer Distribution Inc

Medically reviewed on April 25, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-090

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.

Meijer Distribution, Inc. DayTime NiteTime Cold & Flu Drug Facts

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Active ingredient for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose 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
relieves runny nose and sneezing (Nighttime only)
nasal congestion (Daytime only)

Warnings

Liver warning: These products contain acetaminophen. The maximum daily dose of these products is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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, 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 these products.
to make a child sleepy (Nighttime only)
if you have ever had an allergic reaction to these products or any of their ingredients

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 such as emphysema or chronic bronchitis (Nighttime only)
persistent or chronic cough as occurs with smoking, asthma, 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
may cause marked drowsiness
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
pain, nasal congestion or cough gets worse or lasts more than 7 days
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. (1-800-222-1222) 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 Liver warning
take Nighttime OR Daytime

Nighttime Softgels

do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Daytime Softgels

do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Daytime edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Principal Display Panel - Nighttime

Compare to Vicks® NyQuil® Cold & Flu active ingredients

Liquid Capsules

Nitetime Cold & Flu

Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Multi-Symptom Relief

Alcohol Free

Relief of: aches, fever, cough, sneezing & runny nose

16 Softgels

Principal Display Panel - Daytime

Compare to Vicks® DayQuil® Cold & Flu active ingredients.

Non-Drowsy

DayTime Cold & Flu

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Multi-Symptom Relief

Alcohol Free/Antihistamine Free

Relief of: aches, fever, cough & nasal congestion

32 Softgels

DAYTIME NITETIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-090
Packaging
#Item CodePackage Description
1NDC:41250-090-721 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 18 BLISTER PACK 16 
Part 216 BLISTER PACK 32 
Part 1 of 2
NITETIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, 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 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULE (OBLONG) Size20mm
FlavorImprint CodeL977
Contains    
Packaging
#Item CodePackage Description
18 BLISTER PACK in 1 CARTON
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/11/2014
Part 2 of 2
DAYTIME COLD AND FLU  NON DROWSY
aetaminophen, dextromethorphan hbr, phenylephrine hcl 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) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeL994
Contains    
Packaging
#Item CodePackage Description
116 BLISTER PACK in 1 CARTON
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/11/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/11/2014
Labeler - Meijer Distribution Inc (006959555)

 
Meijer Distribution Inc

← See all daytime nitetime cold and flu 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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