Cold and Flu

Manufacturer: QUALITY CHOICE (Chain Drug Marketing Association)
Effective date: 2025-12-16
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:25:46

Label at a glance#

ProductCold and Flu Nighttime

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Label structure10 sections

Indications and uses

temporarily relieves these common cold/flu symptoms: minor aches and pains headache fever sore throat runny nose and sneezing cough due to minor throat and bronchial irritation

Dosage and administration

do not take more than directed (see overdose warning ) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device mL= milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: donot use When using other Day Time or Night Time products, carefully read each label to ensure corre...

Storage and handling

each 30 mL contains: potassium 5 mg each 30 mL contains : sodium 24 mg Store between 20-25ºC (68-77º). Do not refrigerate.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-248-449-9300

Websitewww.qualitychoice.com

www.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold/flu symptoms:

minor aches and pains
headache
fever
sore throat
runny nose and sneezing
cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day 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

OTC - DO NOT USE SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
glaucoma
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 an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

sedatives or tranquilizers
the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain or cough gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)
do not take more than 4 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
mL= milliliter
keep dosing cup with product
adults and children 12 years and over: 30 mL every 6 hours
children under 12 years of age: donot use
When using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

each 30 mL contains: potassium 5 mg
each 30 mL contains: sodium 24 mg
Store between 20-25ºC (68-77º). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in VICKS® NYQUIL® Cold & Flu

Nighttime

Cold & Flu

Acetaminophen

Dextromethorphan HBr

Doxylamine succinate

For relief of:

Aches | fever | Cough

Runny Nose & Sneezing

For Ages 12 Years & Over

Nighttime Relief

Alcohol 10%

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAPIS BROKEN OR MISSING.

43157 W.Nine Mile

Novi. MI 48375

www.qualitychoice.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1043400	Acetaminophen/Dextromethorphan/Doxylamine (Oral Liquid)	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	8
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	8
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	8
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	8
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
DOXYLAMINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0635515900097	GTIN-13: 0635515900097 EAN-13: 0635515900097 GTIN-12: 635515900097 UPC-A: 635515900097 GTIN storage (14 digits): 00635515900097	nighttime-cold-and-flu-cherry-flavor-delisted-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-234-08	2023-05-10	C162847	48780-1	f386c64a-02e7-0266-e053-dadaa90a7c1a	Drug Facts
63868-234-12	2023-05-10	C162847	48780-1	f386c64a-02e7-0266-e053-dadaa90a7c1a	Drug Facts
63868-234-08	2023-01-30	C162847	48780-1	f386c64a-02e7-0266-e053-dadaa90a7c1a	Drug Facts
63868-234-12	2023-01-30	C162847	48780-1	f386c64a-02e7-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-234-08	Cold and FluNighttime	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		8
63868-234-12	Cold and FluNighttime	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-234-08	ML - Milliliter	63868-234	c220f551-0dc7-44f3-8f63-6a077c7855b6	1	2022-10-06
63868-234-12	ML - Milliliter	63868-234	c7961ede-03a9-4755-9ef9-9492c55d4aaf	1	2020-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Cold and Flu Nighttime
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
DOXYLAMINE SUCCINATE
DOXYLAMINE
ACESULFAME POTASSIUM
ALCOHOL
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-234	63868-234-12, 63868-234-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
DOXYLAMINE SUCCINATE	V9BI9B5YI2	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ALCOHOL	3K9958V90M	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier ndc (package): 63868-234-12 ndc (package): 63868-234-08 ndc (product): 63868-234 ndc11 (package): 63868023408 ndc11 (package): 63868023412 spl id: 970d9c21-b0c9-455e-993c-d333dd08245a spl set id: e70d0784-53bc-4910-aade-3c9ad6e36441

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.