Night Time Severe Cold and Flu
- Manufacturer
- Walgreen Company | AptaPharma Inc.
- Effective date
- 2023-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
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 SECTION
Purpose
Acetaminophen ...................Pain reliever/Fever reducer
Dextromethorphan HBr........Cough suppressant
Doxylamine Succinate .........Antihistamine
Phenylephrine HCl ...............Nasal decongestant
INDICATIONS & USAGE SECTION
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 SECTION
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.
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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 - DO NOT USE SECTION
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.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor of pharmacist before use if you are ■ taking sedatives or
tranquilizers ■ taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
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 SECTION
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
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 SAFETY INFORMATION
Other information
■ each 30 mL contains: sodium 45 mg
■ store at room temperature
INACTIVE INGREDIENT SECTION
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 SECTION
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
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 3 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 3 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 3 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 3 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0331-26 | Night Time Severe Cold and Flu | 237 mL in 1 BOTTLE | LIQUID | 237 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-0331 | NIGHT TIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) LIQUID [WALGREEN COMPANY] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231230_de2b2e34-62a5-451f-ab68-531d1c9d4d82.zip |
Products#
Every source-derived product name is available through these pages.
- Night Time Severe Cold and Flu
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0331 | 0363-0331-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Night Time Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | de2b2e34-62a5-451f-ab68-531d1c9d4d82 | 2023-12-29 | Warnings | 0363-0331-26 0363-0331 00363033126 6e90a856-b1f6-4a6e-bf4c-b341d3e1cee7 de2b2e34-62a5-451f-ab68-531d1c9d4d82 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
