The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Night Time Severe Cold And Flu (NDC 0363-0331). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, other safety information, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
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.
Other information
■ each 30 mL contains: sodium 45 mg
■ store at room temperature
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 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.
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
| 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
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.
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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