DAYTIME NITETIME- acetaminophen, dextromethorphan hbr, doxylamine s uccinate,

phenylephrine hcl
Meijer Dis tribution Inc
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 Dis tribution, Inc. DayTime NiteTime Drug Facts
Active ingredients for NIGHTTIME (in each s oftgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Active ingredients for DAYTIME (in each s oftgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpos e (NIGHTTIME ONLY)
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Purpos e (DAYTIME ONLY)
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Us es
temporarily relieves common cold/flu symptoms:
nasal congestion (DAYTIME ONLY)
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
relieves runny nose and sneezing (NIGHTTIME ONLY)
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
more than 8 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which

is the maximum daily amount

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.
Do not us e
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 Parkinsons 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
As k a doctor before us e if you have
heart disease (DAYTIME ONLY)
thyroid disease (DAYTIME ONLY)
diabetes (DAYTIME ONLY)
high blood pressure (DAYTIME ONLY)
cough that occurs with too much phlegm (mucus)
liver disease
persistent or chronic cough as occurs with smoking, asthma or emphysema
trouble urinating due to an enlarged prostate gland
glaucoma (NIGHTTIME ONLY)
a breathing problem such as emphysema or chronic bronchitis (NIGHTTIME ONLY)
As k a doctor or pharmacis t before us e if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin
When us ing thes e 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 us e and as k 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 breas t-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 recommended - see Liver warning
take Nighttime OR Daytime
NIGHTTIME SOFTGELS
do not exceed 4 doses per 24 hours
adults and children 12 years and over
children 4 to under 12 years
children under 4 years

2 softgels with water every

6 hours
ask a doctor
do not use

DAYTIME SOFTGELS
do not exceed 6 doses per 24 hours
adults and children 12 years and over
children 4 to under 12 years
children under 4 years

2 softgels with water every

4 hours
ask a doctor
do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other information
store at 20-25C (68-77F)
Inactive ingredients
NIGHTTIME D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol,
polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
DAYTIME edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene
glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Ques tions or comments ?
1-800-719-9260
Principal Dis play Panel
SEE NEW WARNINGS INFORMATION
DayTime

non-drowsy
cold/flu relief
Relieves Major Cold and Flu Symptoms Through Your Day
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT / NASAL DECONGESTANT
DOES NOT CONTAIN PSEUDOEPHEDRINE
Acetaminophen aches, fever
Dextromethorphan HBr cough
Phenylephrine HCl nasal congestion
ALCOHOL FREE
ANTIHISTAMINE FREE
DAYTIME
NiteTime
multi-symptom
cold/flu relief
Relieves Cold and Flu Symptoms So You Can Rest
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT / ANTIHISTAMINE
DOES NOT CONTAIN PSEUDOEPHEDRINE
Acetaminophen aches, fever
Dextromethorphan HBr cough
Doxylamine Succinate sneezing, runny nose
COMPARE TO VICKS NYQUIL AND VICKS DAYQUIL LIQUICAPS active ingredients
NITETIME

DayTime NiteTime Carton Imag e 1

DayTime NiteTime Carton Imag e 2

DAYTIME NITETIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
HUMAN O TC DRUG

Prod uct T yp e

NDC:41250 -0 9 0

Ite m Cod e (S ource )

Packag ing
#

Item Co de

Packag e Descriptio n

1 NDC:41250 -0 9 0 -0 5

Marketing Start Date

Marketing End Date

1 in 1 CARTO N

Quantity of Parts
Part #

Packag e Quantity

T o tal Pro duct Quantity

Pa rt 1 2 BLISTER PACK

20

Pa rt 2 2 BLISTER PACK

20

Part 1 of 2
NITETIME
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Route of Ad minis tration

O RAL

Active Ing redient/Active Moiety

Ing redient Name

Basis o f Streng th

Streng th

ACETAMINO PHEN (UNII: 36 2O 9 ITL9 D) (ACETAMINO PHEN - UNII:36 2O 9 ITL9 D)

ACETAMINO PHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTRO METHO RPHAN - UNII:7355X3RO TS)

DEXTRO METHO RPHAN

HYDRO BRO MIDE

15 mg

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DO XYLAMINE - UNII:9 5Q B77JKPL) DO XYLAMINE SUCCINATE

Inactive Ing redients

6 .25 mg

Ing redient Name

Streng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ 3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G8 6 Q N327L)
GLYCERIN (UNII: PDC6 A3C0 O X)
MANNITO L (UNII: 3O WL53L36 A)
PO LYETHYLENE GLYCO LS (UNII: 3WJQ 0 SDW1A)
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q 16 7V3)
WATER (UNII: 0 59 Q F0 KO 0 R)
SO RBITAN (UNII: 6 O 9 2ICV9 RU)
SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics
Color

GREEN

S core

no sc o re

S hap e

CAPSULE

S iz e

20 mm

Imp rint Cod e

L9 77

Flavor
Contains

Packag ing
#

Item Co de

Packag e Descriptio n

Marketing Start Date

Marketing End Date

10 in 1 BLISTER PACK

Marketing Information
Marke ting Cate gory
O TC mo no gra ph fina l

Ap p lication Numb e r or Monograp h Citation

pa rt341

Marke ting S tart Date

Marke ting End Date

0 8 /10 /20 0 7

Part 2 of 2
DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Route of Ad minis tration

O RAL

Active Ing redient/Active Moiety

Ing redient Name

Basis o f Streng th

Streng th

ACETAMINO PHEN (UNII: 36 2O 9 ITL9 D) (ACETAMINO PHEN - UNII:36 2O 9 ITL9 D)

ACETAMINO PHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTRO METHO RPHAN - UNII:7355X3RO TS)

DEXTRO METHO RPHAN

HYDRO BRO MIDE

10 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

PHENYLEPHRINE

5 mg

UNII:1WS29 7W6 MV)

5 mg

HYDRO CHLO RIDE

Inactive Ing redients

Ing redient Name

Streng th

FD&C RED NO . 4 0 (UNII: WZB9 127XO A)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
GELATIN (UNII: 2G8 6 Q N327L)
GLYCERIN (UNII: PDC6 A3C0 O X)
MANNITO L (UNII: 3O WL53L36 A)
PO LYETHYLENE GLYCO LS (UNII: 3WJQ 0 SDW1A)
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q 16 7V3)
WATER (UNII: 0 59 Q F0 KO 0 R)
SO RBITAN (UNII: 6 O 9 2ICV9 RU)
SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics
Color

O RANGE

S core

no sc o re

S hap e

CAPSULE

S iz e

20 mm

Imp rint Cod e

L9 9 4

Flavor
Contains

Packag ing
#

Item Co de

Packag e Descriptio n

Marketing Start Date

Marketing End Date

10 in 1 BLISTER PACK

Marketing Information
Marke ting Cate gory
O TC mo no gra ph fina l

Ap p lication Numb e r or Monograp h Citation

pa rt341

Marke ting S tart Date

Marke ting End Date

0 8 /10 /20 0 7

Marketing Information
Marke ting Cate gory
O TC mo no gra ph fina l

Labeler -

Ap p lication Numb e r or Monograp h Citation

pa rt341

Marke ting S tart Date

Marke ting End Date

0 8 /10 /20 0 7

Meijer Dis tribution Inc (006959555)

Revised: 5/2012

Meijer Distribution Inc