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.

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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

                         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

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

0331-26.jpg

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NIGHT TIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorgreen (Original Cough Syrup Flavor) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0331-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/13/2020
Labeler - Walgreen Company (008965063)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(0363-0331)

Revised: 12/2020
Document Id: 4dca91c8-d7fb-4dfb-8ee9-679e542743c3
Set id: de2b2e34-62a5-451f-ab68-531d1c9d4d82
Version: 2
Effective Time: 20201209
 
Walgreen Company