FDA Label for Night Time Severe Cold And Flu

Other

Drug Facts

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.

Otc - Active Ingredient

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

Otc - Purpose

Purpose
Acetaminophen ...................Pain reliever/Fever reducer
Dextromethorphan HBr........Cough suppressant
Doxylamine Succinate .........Antihistamine
Phenylephrine HCl ...............Nasal decongestant

Indications & 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

Warnings

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. 

Otc - Do Not Use

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.

Other Safety Information

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.

Other information
■ each 30 mL contains: sodium 45 mg
■ store at room temperature

Otc - Ask Doctor/Pharmacist

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

tranquilizers ■ taking the blood thinning drug warfarin.

Otc - When Using

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.

Otc - Stop Use

Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless ■ redness
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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

Directions

■ take only as recommended.  See Warnings

■ use dose cup or tablespoon (TBSP)

■ do not exceed 4 doses per 24 hours

■ do not exceed 4 doses per 24 hours

Inactive Ingredient

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

Otc - Questions

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

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