Mucinex Sinus-Max Day Night

Manufacturer: Reckitt Benckiser LLC
Effective date: 2014-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:34:19

Label at a glance#

ProductMucinex Sinus-Max Day Night Maximum Strength

Active ingredientAcetaminophen, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride

Label structure11 sections

Indications and uses

temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure runny nose and sneezing (Mucinex SINUS-MAX Night only) temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex SINUS-MAX Day only)

Dosage and administration

do not take more than directed (see Overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years and older: take 2 caplets every 4 hours children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-682-4639

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet) Mucinex SINUS-MAX Day	Purpose
Acetaminophen 325 mg	Pain reliever
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant
Active ingredients (in each caplet) Mucinex SINUS-MAX Night	Purpose
Acetaminophen 325 mg	Pain reliever
Diphenhydramine HCl 25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- runny nose and sneezing (Mucinex SINUS-MAX Night only)
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex SINUS-MAX Day only)

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs that contain acetaminophen
3 or more alcoholic drinks daily while using this product

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.
with any other drug containing diphenhydramine, even one used on the skin (Mucinex SINUS-MAX Night only)
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
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
glaucoma (Mucinex SINUS-MAX Night only)
a breathing problem such as emphysema or chronic bronchitis (Mucinex SINUS-MAX Night only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema (Mucinex SINUS-MAX Day only)
cough that occurs with too much phlegm (mucus) (Mucinex SINUS-MAX Day only)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Mucinex SINUS-MAX Night only)

When using this product

OTC - WHEN USING SECTION

do not use more than directed
excitability may occur, especially in children (Mucinex SINUS-MAX Night only)
marked drowsiness may occur (Mucinex SINUS-MAX Night only)
alcohol, sedatives and tranquilizers may increase drowsiness (Mucinex SINUS-MAX Night only)
avoid alcoholic drinks (Mucinex SINUS-MAX Night only)
be careful when driving a motor vehicle or operating machinery (Mucinex SINUS-MAX Night only)

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness or sleeplessness occur
pain or nasal congestion 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 persistent headache. These could be signs of a serious condition. (Mucinex SINUS-MAX Day only)

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 12 caplets in any 24-hour period
adults and children 12 years and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients (Mucinex SINUS-MAX Day)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients (Mucinex SINUS-MAX Night)

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

Made in England (Mucinex SINUS-MAX Day)

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH*

NDC 63824-202-20

NEW

Mucinex®
SINUS-MAX™

Day

Acetaminophen - Pain Reliever • Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

10
CAPLETS

Relieves Sinus Pressure,
Headache & Congestion
Thins & Loosens Mucus

For Ages 12+

Night

Acetaminophen - Pain Reliever • Diphenhydramine HCl - Antihistamine
Phenylephrine HCl - Nasal Decongestant

Relieves Nasal Congestion,
Sinus Pressure & Pain
Relieves Runny Nose
& Sneezing

10
CAPLETS

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-202-20	2023-08-24	C162847	48780-1	9d75b9cf-e26d-f424-e053-dadaa90a57ce	Mucinex® Sinus-Max™ Day Night Maximum Strength
63824-202-20	2020-01-31	C162847	48780-1	9d75b9cf-e26d-f424-e053-dadaa90a57ce	Mucinex® Sinus-Max™ Day Night Maximum Strength

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-202-20	EA - Each	63824-202	823cf731-8cb1-4128-a136-5828a0de42e1	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	2
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	2
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	2
crospovidone	INACTIVE INGREDIENT	68401960MK	2
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	2
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	2
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	2
triacetin	INACTIVE INGREDIENT	XHX3C3X673	2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

Mucinex Sinus-Max Day Night Maximum Strength
Acetaminophen, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride
Mucinex Sinus-Max Day Maximum Strength
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Acetaminophen
Guaifenesin
Phenylephrine Hydrochloride
Phenylephrine
croscarmellose sodium
crospovidone
FD&C red no. 40
FD&C yellow no. 6
aluminum oxide
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
polyvinyl alcohol
povidones
talc
titanium dioxide
Mucinex Sinus-Max Night Maximum Strength
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Diphenhydramine Hydrochloride
Diphenhydramine
starch, corn
FD&C blue no. 1
hypromelloses
polydextrose
silicon dioxide
stearic acid
triacetin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-202	63824-202-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
Guaifenesin	495W7451VQ	ACTIB
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
croscarmellose sodium	M28OL1HH48	IACT
crospovidone	68401960MK	IACT
FD&C red no. 40	WZB9127XOA	IACT
FD&C yellow no. 6	H77VEI93A8	IACT
aluminum oxide	LMI26O6933	IACT
magnesium stearate	70097M6I30	IACT
cellulose, microcrystalline	OP1R32D61U	IACT
polyethylene glycols	3WJQ0SDW1A	IACT
polyvinyl alcohol	532B59J990	IACT
povidones	FZ989GH94E	IACT
talc	7SEV7J4R1U	IACT
titanium dioxide	15FIX9V2JP	IACT
Acetaminophen	362O9ITL9D	ACTIB
Diphenhydramine Hydrochloride	TC2D6JAD40	ACTIB
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
starch, corn	O8232NY3SJ	IACT
croscarmellose sodium	M28OL1HH48	IACT
crospovidone	68401960MK	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
aluminum oxide	LMI26O6933	IACT
hypromelloses	3NXW29V3WO	IACT
magnesium stearate	70097M6I30	IACT
cellulose, microcrystalline	OP1R32D61U	IACT
polydextrose	VH2XOU12IE	IACT
polyethylene glycols	3WJQ0SDW1A	IACT
povidones	FZ989GH94E	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
stearic acid	4ELV7Z65AP	IACT
titanium dioxide	15FIX9V2JP	IACT
triacetin	XHX3C3X673	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 · 453 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	DROPS / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
polyvinyl alcohol	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
polyvinyl alcohol	POLYVINYL ALCOHOL	532B59J990	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	CONCENTRATE / ORAL		250 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
polyvinyl alcohol	POLYVINYL ALCOHOL	532B59J990	SOLUTION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / BUCCAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
polyvinyl alcohol	POLYVINYL ALCOHOL	532B59J990	SUSPENSION / AURICULAR (OTIC)	0.05 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 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
fbc17f49-4826-c01b-e053-6294a90a8cbc			b0a4b6f6-9cbd-4606-a559-87c06195ac2c	2023-05-15	Warnings	Exact identifier spl set id: b0a4b6f6-9cbd-4606-a559-87c06195ac2c

Reported adverse events (FAERS/openFDA)#

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