DAY TIME AND NIGHT TIME SINUS AND CONGESTION

Main information

  • Trade name:
  • DAY TIME AND NIGHT TIME SINUS AND CONGESTION- acetaminophen, doxylamine succinate, phenylephrine hcl
  • Composition:
  • ACETAMINOPHEN 325 mg
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DAY TIME AND NIGHT TIME SINUS AND CONGESTION- acetaminophen, doxylamine succinate, phenylephrine hcl
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Pain reliever/fever reducer Nasal decongestant Pain reliever/Fever reducer Antihistamine Nasal decongestant temporarily relieves symptoms due to common cold: - minor aches and pains - headache - fever - nasal and sinus congestion - sinus congestion & pressure temporarily relieves symptoms due to common cold: - minor aches and pains - headache - fever - runny nose and sneezing   - nasal congestion - sinus congestion & pressure

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 0363-1035-03
  • Last update:
  • 20-06-2019

Summary of Product characteristics: dosage, interactions, side effects

DAY TIME AND NIGHT TIME SINUS AND CONGESTION- acetaminophen, doxylamine

succinate, phenylephrine hcl

Walgreens 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.

----------

Day Time and Night Time Sinus & Congestion

Active ingredients for DAYTIME ONLY (in each LiquidCap)

Acetaminophen

Phenylephrine HCI

Active ingredients for NIGHTTIME (in each LiquidCap)

Acetaminophen

Doxylamine succinate

Phenylephrine hydrochloride

Purpose (DAYTIME ONLY)

Pain reliever/fever reducer

Nasal decongestant

Purpose (NIGHTTIME ONLY)

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Uses (DAYTIME ONLY)

temporarily relieves symptoms due to common cold:

minor aches and pains

headache

fever

nasal and sinus congestion

sinus congestion & pressure

Uses (NIGHTTIME ONLY)

temporarily relieves symptoms due to common cold:

minor aches and pains

headache

fever

runny nose and sneezing

nasal congestion

sinus congestion & pressure

Warnings (DAYTIME ONLY)

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

more than 4 doses in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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

Ask a doctor before use if you have

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

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

When using this product, do not use more than directed.

Stop use and ask doctor if

pain or nasal congestion 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

you get nervous, dizzy or sleepless

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.

Warnings (NIGHTTIME ONLY)

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

more than 4 doses in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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

Ask a doctor before use if you have

liver disease

heart disease

thyroid disease

diabetes

high blood pressure

glaucoma

trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product

do not use more than directed.

excitability may occur, especially in children

marked drowsiness may occur

avoid alcoholic drinks

excitability may occur, especially in children

alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask doctor if

pain or nasal congestion 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

you get nervous, dizzy or sleepless

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 (DAYTIME ONLY)

take only as directed

do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Directions (NIGHTTIME)

take only as directed

do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information

store at controlled room temperature 15°C to 30°C (59°F to 86°F)

Inactive ingredients (DAYTIME ONLY)

edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol –may contain this ingredient

Inactive ingredients (NIGHTTIME)

edible white ink, FD&C blue #1*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol

Inactive ingredients (NIGHTTIME)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol,

povidone, propylene glycol, purified water, sortitian, sorbitol

Questions or comments?

1-800-706-5575

Principal Display Panel

Combo Pack

NON-DROWSY DAYTIME

Sinus & Congestion

Acetaminophen / Sinus Headache

& Pain / Phenylephrine HCl /

Sinus Pressure & Congestion

32 LIQUID CAPS

NIGHTTIME

Sinus & Congestion

Acetaminophen / Sinus Headache

& Pain / Doxylamine Succinate /

Runny Nose / Phenylephrine HCl /

Sinus Pressure & Congestion

16 LIQUID CAPS

Compare to Vicks

QlearQuil™ Day/Night Sinus & Congestion Liquicaps

48 TOTAL LIQUID CAPS

DAY TIME AND NIGHT TIME SINUS AND CONGESTION

acetaminophen, doxylamine succinate, phenylephrine hcl kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-10 35

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-10 35-0 3

1 in 1 CARTON; Type 1: Co nvenience Kit o f Co -Package

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BLISTER PACK

Pa rt 2

1 BLISTER PACK

Part 1 of 2

DAY TIME SINUS AND CONGESTION

acetaminophen, 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

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 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 NE (UNII: FZ9 8 9 GH9 4E)

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

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

9 5A

Contains

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

32 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

0 3/0 1/20 13

Part 2 of 2

NIGHT TIME SINUS AND CONGESTION

acetaminophen, doxylamine succinate, 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

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

DOXYLAMINE SUCCINATE

6 .25 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 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)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

Contains

Walgreens Company

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

16 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

0 3/0 1/20 13

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 /0 1/20 14

Labeler -

Walgreens Company (008965063)

Registrant -

Apotex Inc. (209429182)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Accucaps Industries Limited

248 441727

analysis(0 36 3-10 35) , manufacture(0 36 3-10 35)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Accucaps Industries Limited Strathro y

2439 440 50

analysis(0 36 3-10 35) , manufacture(0 36 3-10 35)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Legacy Pharmaceutical Packaging

9 6 9 8 52743

pa c k(0 36 3-10 35)

Revised: 5/2015