Sanatos

Manufacturer: Pharmalab Enterprises Inc
Effective date: 2010-09-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:25:46

Label at a glance#

ProductSanatos Night

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Label structure14 sections

Contacts and useful links#

PhoneLabel contact(302) 725-0692

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                               Purpose

(in each 15 mL tablespoon)

Acetaminophen 500mg........         Pain Reliever/Fever Reducer

Dextromethorphan HBr 15mg......    Cough Suppressant

Doxylamine succinate 6.25mg..................Antihistamine

OTC - PURPOSE SECTION

Uses: temporarily relieves common cold/flu symptoms:

Cough due to Minor Throat and Bronchial Irritation
Sore Throat
Headache
Minor Aches and Pains
Fever
runny nose and sneezing

WARNINGS SECTION

Warnings: Do not exceed recommended dosage.

Do not give to children under 12 years of age.

Liver Toxicity may occur if:

Recommended dosage is exceeded
Used with other products containing acetaminophen
Used with moderate amounts of alcohol

Alcohol Warning: If you consume 3 or more alcoholic drinks, ask your doctor whether you should take acetaminophen or other pain relievers. Acetaminophen may cause liver damage.
Sore Throat Warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use 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 two 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

OTC - ASK DOCTOR SECTION

Stop Use and ask a doctor if you have:

Glaucoma
Trouble urinating due to enlarged prostate gland
Cough that occurs with too much phlegm(mucus)
Persistent or chronic cough as occurs with smoking, asthma or emphysema
Ask a doctor before use if you are taking sedatives or tranquilizers

Ask a doctor before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product, do not use more than directed

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

OTC - STOP USE SECTION

Stop Use and ask a doctor if:

Pain or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back, or occurs with rash or headache that lasts. This could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant of breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: 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. Prompt 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 Overdose Warning.

use dose cup or tablespoon(TBSP). Do not use more than 4 doses in 24 hours

Adults and children 12 years and older: Take 2 TBSP(30ml) every 6 hours, while symptoms persist or as directed by a doctor

Children under 12 years of age: Consult a doctor. Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.

INDICATIONS & USAGE SECTION

Other information:

Store at controlled room temperature 15-30 C (59-86F)
each tablespoon contains: potassium 5 mg, sodium 18 mg. Contains 10% alcohol.

OTC - QUESTIONS SECTION

Questions? (302) 725-0692

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaTosNightLabel

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1042684	Acetaminophen/Dextromethorphan/Doxylamine (Oral Liquid)	acetaminophen 33.3 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
1042684	acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution	PSN	2
1042684	acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	2
1042684	acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	2
1042684	acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	2
1042684	APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	2

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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
14505-399-06	2019-10-21	C162847	48780-1	956f9ecf-defc-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14505-399-06	SanatosNight	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14505-399	SANATOS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [PHARMALAB ENTERPRISES INC]	2	Legacy NDC, 1 package rows	20100909_8816ec3c-2a26-4bd5-9ba6-8f7fce999470.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Sanatos Night
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
DOXYLAMINE SUCCINATE
DOXYLAMINE
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM CHLORIDE
SODIUM CITRATE
ALCOHOL
D&C YELLOW NO. 10
FD&C GREEN NO. 3
HIGH FRUCTOSE CORN SYRUP

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
14505-399	14505-399-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
FD&C YELLOW NO. 6	H77VEI93A8	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
ALCOHOL	3K9958V90M	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
PROPYLENE GLYCOL	6DC9Q167V3	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 8 · 479 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SUPPOSITORY / RECTAL	0.02 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 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 candidate 31 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / DENTAL	0.4 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 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
af1e5459-2fd9-4c0f-af63-bea42e73c14d			8816ec3c-2a26-4bd5-9ba6-8f7fce999470	2010-09-09	Warnings	Exact identifier spl id: af1e5459-2fd9-4c0f-af63-bea42e73c14d spl set id: 8816ec3c-2a26-4bd5-9ba6-8f7fce999470

Reported adverse events (FAERS/openFDA)#

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