DAYTIME

Main information

  • Trade name:
  • DAYTIME NITETIME COLD AND FLU acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl
  • Composition:
  • ACETAMINOPHEN 325 mg
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DAYTIME NITETIME COLD AND FLU acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

DAYTIME NITETIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine

succinate, phenylephrine hcl

Kroger Company

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.

----------

Kroger Co. DayTime NiteTime Cold & Flu Drug Facts

Active ingredients (in each softgel) – Nighttime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients (in each softgel) - Daytime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose – Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose – Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses – Nighttime Cold & Flu

temporarily relieves common cold/flu symptoms:

Uses – Daytime Cold & Flu

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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

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

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by

fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have – Nighttime Cold & Flu

Ask a doctor before use if you have – Daytime Cold & Flu

nasal congestion

cough due to minor throat and bronchial irritation

sore throat

headache

minor aches and pains

fever

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

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.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem such as emphysema or chronic bronchitis

persistent or chronic cough as occurs with smoking, asthma, or emphysema

trouble urinating due to an enlarged prostate gland

liver disease

heart disease

high blood pressure

Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu

Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu

taking the blood thinning drug warfarin

When using this product – Nighttime Cold & Flu

When using this product – Daytime Cold & Flu

do not use more than directed

Stop use and ask a doctor if – Nighttime Cold & Flu

These could be signs of a serious condition.

Stop use and ask a doctor if – Daytime Cold & Flu

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.

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

cough that occurs with too much phlegm (mucus)

persistent or chronic cough as occurs with smoking, asthma, or emphysema

taking sedatives or tranquilizers

taking the blood thinning drug warfarin

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

pain or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts.

you get nervous, dizzy or sleepless

pain, nasal congestion or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts.

Overdose warning: 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 – Nighttime Cold & Flu

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

Directions – Daytime Cold & Flu

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

Other information

Inactive ingredients – Nighttime Cold & Flu

D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution

Inactive ingredients – Daytime Cold & Flu

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of VICKS® DAYQUIL® COLD & FLU LIQUICAPS®

See side panel

SEE NEW WARNINGS

NON-DROWSY

DayTime

take only as directed – see overdose warning

do not exceed 4 doses per 24 hrs

take only as directed – see overdose warning

do not exceed 4 doses per 24 hrs

store at 20-25 C (68-77 F)

COLD & FLU

Acetaminophen, Pain Reliever, Fever Reducer

Dextromethorphan HBr, Cough Suppressant

Phenylephrine HCl, Nasal Decongestant

Aches, Fever, Sore Throat

Nasal Congestion

Cough

32 SOFTGELS

actual size

COMPARE TO the active ingredients of VICKS® NYQUIL® COLD & FLU LIQUICAPS®

See side panel

SEE NEW WARNINGS

NiteTime

COLD & FLU

Acetaminophen, Pain Reliever, Fever Reducer

Dextromethorphan HBr, Cough Suppressant

Doxylamine Succinate, Antihistamine

Aches, Fever, Sore Throat

Sneezing, Runny Nose

Cough

16 SOFTGELS

actual size

DAYTIME NITETIME COLD AND FLU

acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-222

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-222-72

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

8 BLISTER PACK

Pa rt 2

16 BLISTER PACK

Part 1 of 2

NITETIME COLD AND FLU

acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

15 mg

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

6 .25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PO VIDO NES (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

CAPSULE (OBLONG)

S iz e

20 mm

Flavor

Imprint Code

L9 77

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

8 in 1 KIT

1

2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

10 /0 6 /20 14

Part 2 of 2

DAYTIME COLD AND FLU

aetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PO VIDO NES (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

CAPSULE

S iz e

20 mm

Flavor

Imprint Code

L9 9 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

16 in 1 KIT

1

2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Kroger Company

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 9 /30 /20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

11/0 3/20 14

Labeler -

Kroger Company (006999528)

Revised: 8/2015