COLD AND FLU DAYTIME, NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

Beli sekarang

Ciri produk Ciri produk (SPC)

04-12-2020

Bahan aktif:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Boleh didapati daripada:
Walgreen Company
Jenis preskripsi:
OTC DRUG
Tanda-tanda terapeutik:
Pain reliever/fever reducer Cough suppressant Nasal decongestant Pain reliever/fever reducer Cough suppressant Antihistamine - temporarily relieves common cold and flu symptoms: fever headache sore throat minor aches and pains cough due to minor throat and bronchial irritation nasal congestion (Daytime only) runny nose and sneezing (Nighttime only) - fever - headache - sore throat - minor aches and pains - cough due to minor throat and bronchial irritation - nasal congestion (Daytime only) - runny nose and sneezing (Nighttime only)
Status kebenaran:
OTC monograph final
Nombor kebenaran:
0363-7331-08

Baca dokumen lengkap

COLD AND FLU DAYTIME, NIGHTTIME- acetaminophen, dextromethorphan hbr,

doxylamine succinate, phenylephrine hcl

Walgreen 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.

----------

Walgreens 44-730731-08

Active ingredients (in each liquid-filled capsule) (Daytime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold and flu symptoms:

fever

headache

sore throat

minor aches and pains

cough due to minor throat and bronchial irritation

nasal congestion (Daytime only)

runny nose and sneezing (Nighttime only)

Warnings

Liver warning: This product contains acetaminophen. 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 this product

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

skin reddening

blisters

rash

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

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 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.

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

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)

liver disease

difficulty in urination due to enlargement of the prostate gland

heart disease (Daytime only)

diabetes (Daytime only)

thyroid disease (Daytime only)

high blood pressure (Daytime only)

persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)

a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic

bronchitis, or emphysema (Nighttime only)

glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers (Nighttime only)

When using this product

do not exceed recommended dosage

excitability may occur, especially in children (Nighttime only)

avoid alcoholic beverages (Nighttime only)

marked drowsiness may occur (Nighttime only)

alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur (Daytime only)

pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)

pain or cough gets worse or lasts more than 7 days (Nighttime only)

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. 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt

medical attention is critical for adults as well as for children even if you do not notice any signs or

symptoms.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same

time.

Directions (Daytime only)

do not take more than directed

do not take more than 8 capsules per 24 hours

adults and children 12 years and over: take 2 capsules with water every 4 hours

children under 12 years: ask a doctor

Directions (Nighttime only)

do not take more than directed

do not take more than 8 capsules per 24 hours

adults and children 12 years and over: take 2 capsules with water every 6 hours

children under 12 years: ask a doctor

Do not take more than 8 capsules of Daytime and Nighttime products in any 24-hour period.

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

protect from light, heat and moisture

see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides,

polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Inactive ingredients (Nighttime only)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides,

polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-426-9391

Principal Display Panel

DAY & NIGHT PACK

NDC 0363-7331-08

Walgreens

Compare to Vicks

DayQuil

& NyQuil

Cold & Flu LiquiCaps

active ingredients

DAYTIME NON-DROWSY

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER

REDUCER

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

PHENYLEPHRINE HCl /

NASAL DECONGESTANT

MULTI-SYMPTOM

ACTUAL

SIZE

16

LIQUID

CAPS

NIGHTTIME

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER

REDUCER

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE /

ANTIHISTAMINE

MULTI-SYMPTOM

ACTUAL

SIZE

8

LIQUID

CAPS

24 TOTAL LIQUID CAPS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

This product is not manufactured or distributed by The Procter & Gamble Company, owner of the

registered trademark Vicks

DayQuil

& NyQuil

Cold & Flu LiquiCaps

50844 ORG012073073108

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION GUARANTEED

walgreens.com ©2020 Walgreen Co.

PRODUCT OF DUBAI

PACKAGED AND QUALITY

ASSURED IN THE U.S.A.

®

®

®

®

††

††

Walg reens 4 4 -730731

COLD AND FLU DAYTIME, NIGHTTIME

acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-7331

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 36 3-7331-

1 in 1 PACKAGE, COMBINATION; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 4/20 20

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

2 BLISTER PACK

Pa rt 2

1 BLISTER PACK

Part 1 of 2

COLD AND FLU DAYTIME

acetaminophen, 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 )

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

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

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

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

8 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 MONOGRAPH FINAL

pa rt341

12/0 4/20 20

Part 2 of 2

COLD AND FLU NIGHTTIME

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, UNSPECIFIED (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

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

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

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

8 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 MONOGRAPH FINAL

pa rt341

12/0 4/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

12/0 4/20 20

Labeler -

Walgreen Company (008965063)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 36 3-7331)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(0 36 3-7331)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 36 3-7331)

Walgreen Company

Revised: 12/2020

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