NIGHT TIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Walgreen Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Acetaminophen ...................Pain reliever/Fever reducer Dextromethorphan HBr........Cough suppressant Doxylamine Succinate .........Antihistamine Phenylephrine HCl ...............Nasal decongestant Uses Temporarily relieves cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ sore throat ■ headache ■ minor aches and pain ■ runny nose and sneezing ■ temporarily reduces fever ■ cough due to minor throat and bronchial irritation ■ promotes nasal and/or sinus drainage 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
Authorization status:
OTC monograph final
Authorization number:
0363-0331-26

Read the complete document

NIGHT TIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine

succinate, phenylephrine hcl liquid

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.

----------

Night Time Severe Cold & Flu

Drug Facts

Active ingredients

(in each 30 mL dose cup or 2 tablespoons)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine Succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

Acetaminophen ...................Pain reliever/Fever reducer

Dextromethorphan HBr........Cough suppressant

Doxylamine Succinate .........Antihistamine

Phenylephrine HCl ...............Nasal decongestant

Uses Temporarily relieves cold/flu symptoms: ■ nasal

congestion ■ sinus congestion & pressure ■ sore throat

■ headache ■ minor aches and pain ■ runny nose and

sneezing ■ temporarily reduces fever ■ cough due to

minor throat and bronchial irritation ■ promotes nasal

and/or sinus drainage

Warnings 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 ■ with other drugs containing

acetaminophen ■ 3 or more alcoholic drinks daily 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 ■ to make a child sleep.

Ask a doctor before use if you have ■ a sodium

restricted diet. liver disease ■ heart disease ■

glaucoma ■ high blood pressure ■ thyroid disease

■ diabetes. cough that occurs with too much

phlegm (mucus) ■ a breathing problem or chronic

cough that lasts or as occurs with smoking, asthma,

chronic bronchitis or emphysema. trouble

urinating due to enlarged prostate gland.

Ask a doctor of pharmacist before use if you are ■ taking sedatives or

tranquilizers ■ taking the blood thinning drug warfarin.

When using this product ■ do not use more than directed ■ avoid

alcoholic drinks ■ marked drowsiness may occur ■ excitability may occur,

especially in children, ■ 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 sleeplessredness

or swelling is present ■ pain, nasal congestion, or cough gets worse or lasts more

than 7 days ■ fever gets worse or lasts more than 3 days ■ 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 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

■ take only as recommended. See Warnings

■ use dose cup or tablespoon (TBSP)

■ do not exceed 4 doses per 24 hours

Dose

Adults & children 12 years & over

30 mL (2 TBSP) every 4 hours

Children 4 to under 12 years

Ask a doctor

Children under 4 years

Do not use

■ do not exceed 4 doses per 24 hours

Other information

■ each 30 mL contains: sodium 45 mg

■ store at room temperature

Inactive ingredients anhydrous citric acid, dextrose, D&C Yellow # 10, FD&C Green

# 3, FD&C Yellow # 6, flavor, glycerin, propylene glycol, purified water,

saccharin sodium, sodium benzoate, sodium chloride, sorbitol, xanthan gum

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

Product Label

Walgreens

Compare to Vicks

NyQuil™

Severe Nighttime Cold &

Flu Relief active ingredients

NDC 0363-0331-26

NIGHTTIME

Severe Cold & Flu

ACETAMINOPHEN / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

PHENYLPHRINE HCl / NASAL DECONGESTANT

AMAXIMUM STRENGTH

Pain reliever, fever reducer,

cough suppressant, antihistamine

& nasal decongestant

ORIGINAL

FLAVOR

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR TORN

DISTRIBUTED BY WALGREEN CO., 200 WILMONT RD., DEERFIELD, IL 60015

100 % SATISFACTION GUARANTEED walgreens.com@2020WalgreenVo.

LR-151

ORG1020-F

®

††

NIGHT TIME SEVERE COLD AND FLU

acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 331

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

6 50 mg

in 30 mL

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 30 mL

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

UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

12.5 mg

in 30 mL

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

10 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

green (Original Co ugh Syrup Flavo r)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-0 331-26

237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/13/20 20

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

11/13/20 20

Labeler -

Walgreen Company (008965063)

Registrant -

AptaPharma Inc. (790523323)

Walgreen Company

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

AptaPharma Inc.

79 0 523323

ma nufa c ture (0 36 3-0 331)

Revised: 12/2020

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