Flu Relief Therapy Day Time

Manufacturer
P & L Development, LLC
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:55:50

Label at a glance#

ProductFlu Relief Therapy Day Time
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

temporarily relieves • minor aches and pains • headache • minor sore throat pain • nasal congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever

Dosage and administration

• do not exceed recommended dosage (see overdose warning) • do not use in infants age                                                                                dose adults and children 12 years and over....................2 tablespoons (30 mL) every 4 hours children 4 years to under 12 years..........................do not use unless directed by a doctor children under 4 years....................................

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen  325 mg
Dextromethorphan HBr  10 mg
Phenylephrine HCI  5 mg

Purposes

OTC - PURPOSE SECTION

Acetaminophen............................Pain reliever/fever reducer
Dextromethorphan HBr...............Cough suppressant
Phenylephrine HCI......................Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves
• minor aches and pains
• headache • minor sore throat pain
• nasal congestion
• cough due to minor throat and
bronchial irritation
• temporarily reduces fever

Warnings

WARNINGS SECTION

Alcohol warning: If you consume
3 or more alcoholic drinks every day,
ask your doctor whether you should
take acetaminophen or other pain
relievers/fever reducers.
Acetaminophen may cause liver
damage.
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

• if you are on
a sodium-restricted diet
• 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.
• with any other acetaminophen
containing products. This may
lead to an overdose,which may
cause liver damage.
(see overdose warning)

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• heart disease
• thyroid disease • diabetes
• high blood pressure
• persistent or chronic cough such
as occurs with smoking, asthma
or emphysema
• cough accompanied by excessive
phlegm (mucus)
• trouble urinating due to enlarged
prostate gland

When using this product

OTC - WHEN USING SECTION

• do not use more than directed
(see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

• redness or swelling is present
• you get nervous, dizzy or
sleepless
• pain, cough or nasal congestion
gets worse or lasts more than
7 days
• fever gets worse or lasts more
than 3 days
Drug Facts (continued)
• new symptoms occur
• sore throat is severe, persists for
more than 2 days, is
accompanied or followed by
fever, headache, rash, nausea, or
vomiting
• 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 this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose Warning: Taking more
than the recommended dose
(overdose) could cause serious
health problems, including liver
damage. In case of accidental
overdose, seek professional
assistance or contact a Poison
Control Center immediately. 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 exceed recommended
dosage (see overdose warning)
• do not use in infants


age                                                                                dose
adults and children 12 years and over....................2 tablespoons (30 mL) every 4 hours
children 4 years to under 12 years..........................do not use unless directed by a doctor
children under 4 years..............................................do not use

Do not take more than 6 doses
(12 tablespoons) in 24 hours.

Other Information

SPL UNCLASSIFIED SECTION

• sodium content
per tablespoo
n: 8 mg
• store at controlled
room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol,
blue 1, citric acid, edetate disodium,
flavors, glycerin, maltitol solution,
propylene glycol, purified water,
red 40, sodium benzoate,
sodium citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cherry

flu relief therapy

daytime cold and cough

acetaminophen

fever and sore throat

dextromethorphan HBr

cough

phenylephrine HCL

stuffy nose

for ages 12 and over

alcohol 10 percent

manufactured by aaron industries

PO Box 801

Lynwood, CA 90262

compare to the actived ingredients in theraflu

8.3 fl oz (245mL)

image of label
image of label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
DextromethorphanACTIVE MOIETY7355X3ROTS1
PhenylephrineACTIVE MOIETY1WS297W6MV1
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G91
AlcoholINACTIVE INGREDIENT3K9958V90M1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
MaltitolINACTIVE INGREDIENTD65DG142WK1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49580-015549580-0155-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 9 · 504 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDMOUTHWASH / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
Acesulfame PotassiumACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii candidate
17 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKCAPSULE / ORAL155 mgExact identifier — unii candidate
7 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
97fad820-aabf-428b-ae77-d6c61c08a80cb79d0ebb-04f4-4a81-ba30-e2b29dfc30782019-12-04WarningsExact identifier
spl id: 97fad820-aabf-428b-ae77-d6c61c08a80c
spl set id: b79d0ebb-04f4-4a81-ba30-e2b29dfc3078

Reported adverse events (FAERS/openFDA)#

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