Nite-Time

Manufacturer: Salado Sales, Inc. | AptaPharma Inc.
Effective date: 2023-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:06:04

Label at a glance#

ProductNite-Time COLD/FLU ORIGINAL

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Label structure16 sections

Indications and uses

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

Dosage and administration

take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Contacts and useful links#

PhoneLabel contact1-877-795-5944

Websitewww.saladosales.com

www.saladosales.com

Label contents#

Full prescribing information#

Drug FactsActive ingredients (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cold/flu symptoms:

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

Warnings

WARNINGS SECTION

Failure to follow these warnings could result in serious consequences

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 amoun
- 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 ccurs, 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a sodium restricted diet
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 enlarged prostate gland

Ask A Doctor or Pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers
if you are taking the blood thinning drug warfarin

When Using This Product

OTC - WHEN USING SECTION

do not use more than directed
avoid alcoholic drinks
excitability may occur, especially in children
marked drowsiness may occur
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

redness or swelling is present
symptoms do not get better within 7 days or are accompanied by a fever
fever gets worse or lasts more than 3 days
new symptoms occur
cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts

Pregnant Or Breast-Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose Warning

OVERDOSAGE SECTION

Taking more than the recommended dose can cause serious health problems. 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

DOSAGE & ADMINISTRATION SECTION

take only as recommended-see Overdose warnings
Use dose cup or tablespoon (TBSP)
do not exceed 4 doses per 24 hours
If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Other Information

OTHER SAFETY INFORMATION

each 30 mL dose cup contains:
sodium 45 mg
store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

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

to make a child sleepy

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to VICKS® NYQUIL® active ingredients CVP CONSUMER VALUE PRODUCTS

Nite-Time COLD/FLU Medicine

Multi-Symptom ORIGINAL FLAVOR

Acetaminophen ..........................Aches, Fever and Sore Throat

Dextromethorphan ......................Cough

Doxylamine Succinate ................Sneezing, Runny nose

6 FL OZ (177 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-002

Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944

Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503 www.saladosales.com

LOT: EXP:

Peel Here DRUG FACTS CONTINUED ON BACK

ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

Antihistamine

Cough Suppressant

Pain Reliever

Fever Reducer

AptaPharma Night-Time Label

res

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57243-501-25	Nite-TimeCOLD/FLU ORIGINAL	177 mL in 1 BOTTLE	LIQUID	177		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57243-501	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20231230_fcd24753-b42b-4d05-8379-0ec0351ab217.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	6
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	6
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	6
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	6
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	6
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	6
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	6
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

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

Nite-Time COLD/FLU ORIGINAL
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
DOXYLAMINE SUCCINATE
DOXYLAMINE
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
GLYCERIN
POLYETHYLENE GLYCOL 400
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57243-501	57243-501-25

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
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCROSE	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 146 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii+route 42 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route 42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+dosage form 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET / ORAL		240 mg	Exact identifier — unii+route 22 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii+route 42 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route 42 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	ELIXIR / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 38 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, LIQUID FILLED / ORAL	0.03 mg		Exact identifier — unii+route 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii+route 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii+route 42 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 42 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	ELIXIR / ORAL	0.3 mg/15ml		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, EXTENDED RELEASE / ORAL	0.16 mg		Exact identifier — unii+route 22 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii+route 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii+route 42 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SUSPENSION / ORAL		76 mg	Exact identifier — unii+route 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii+route 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii+route 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii+route 42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii+route 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 34 equally ranked IID candidates

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
Nite-Time COLD/FLU ORIGINAL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	fcd24753-b42b-4d05-8379-0ec0351ab217	2023-12-29	Warnings	Exact identifier ndc (package): 57243-501-25 ndc (product): 57243-501 ndc11 (package): 57243050125 spl id: 99da41d1-ae1e-4a3a-b51a-11bed23be8bf spl set id: fcd24753-b42b-4d05-8379-0ec0351ab217

Reported adverse events (FAERS/openFDA)#

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