Night Time Severe Cold & Flu

Night Time Severe Cold & Flu
SPL v3
SPL
SPL Set ID de2b2e34-62a5-451f-ab68-531d1c9d4d82
Route
ORAL
Published
Effective Date 2020-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sorbitol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-13

Description

Drug Facts


Medication Information

Warnings and Precautions

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. 

Indications and Usage

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

Dosage and Administration

Directions

■ take only as recommended.  See Warnings

■ use dose cup or tablespoon (TBSP)

■ do not exceed 4 doses per 24 hours

                         Age                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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

Section 50567-7

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.

Section 50568-5

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

tranquilizers ■ taking the blood thinning drug warfarin.

Section 50570-1

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.

Section 51727-6

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

Section 53413-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

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

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

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

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

Section 55106-9

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

Section 60561-8

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.

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

res


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

■ take only as recommended.  See Warnings

■ use dose cup or tablespoon (TBSP)

■ do not exceed 4 doses per 24 hours

                         Age                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

Warnings and Precautions (34071-1)

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. 

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

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

tranquilizers ■ taking the blood thinning drug warfarin.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

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

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

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

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

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

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.

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

res


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