DayQuil Severe

Manufacturer: Lil' Drug Store Products, Inc
Effective date: 2022-11-21
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 21:47:15

Label at a glance#

ProductDayQuil Severe Cold and Flu

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom...

Dosage and administration

take only as directed do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

each caplet contains: sodium 4 mg do not exceed 25°C

Contacts and useful links#

PhoneLabel contact1-800-251-3374

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- 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.

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

more than 4 doses in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy Alert

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.

Sore throat warning

SPL UNCLASSIFIED SECTION

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
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product, do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you get nervous, dizzy or sleepless
pain, nasal congestion, 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

take only as directed
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	2 caplets with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

STORAGE AND HANDLING SECTION

each caplet contains: sodium 4 mg
do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-251-3374

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DayQuil ™

SEVERE+

VICKS® VapoCOOL™

COLD & FLU

Acetaminophen, Phenylephrine HCl,

Dextromethorphan HBr, Guaifenesin

Minor Aches & Pains, Fever
Nasal/Sinus Congestion & Sinus Pressure
Cough
Chest Congestion

[caplet image]

Non-Drowsy

4
Coated Caplets

[Lil' Drug Store ® logo]

PDP/Package

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1110988	Acetaminophen/Dextromethorphan/guaiFENesin/Phenylephrine (Oral Pill)	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD Active

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	1
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	1
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
Polyvinyl Alcohol	INACTIVE INGREDIENT	532B59J990	1
Povidones	INACTIVE INGREDIENT	FZ989GH94E	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

DayQuil Severe Cold and Flu
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C YELLOW NO. 6
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66715-9704	66715-9704-8, 66715-9704-3, 66715-9704-2, 66715-9704-1, 66715-9704-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

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 7 · 396 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polyvinyl Alcohol	POLYVINYL ALCOHOL	532B59J990	SOLUTION / TOPICAL	1.4 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE PELLETS / ORAL		127 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 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	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE PELLETS / ORAL		32 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Povidones	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Polyvinyl Alcohol	POLYVINYL ALCOHOL	532B59J990	IMPLANT / INTRAVITREAL	0.12 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 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

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
0658d4ba-b8cc-aa54-e063-6394a90ad3a1			fdf4ee2c-fab8-43a8-84e8-e6ff0d262e01	2023-09-27	Warnings	Exact identifier spl set id: fdf4ee2c-fab8-43a8-84e8-e6ff0d262e01

Reported adverse events (FAERS/openFDA)#

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

DayQuil Severe

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Uses

Warnings

Liver warning

Allergy Alert

Sore throat warning

Do not use

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

Related RxNorm Concepts#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#