FDA.reportPublic FDA data

Night Time Severe Cold and Cough Relief

Manufacturer
Chain Drug Consortium, LLC | AptaPharma Inc.
Effective date
2024-12-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:49:30

Label at a glance#

ProductNight Time Severe Cold and Cough Relief
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal and sinus congestion runny nose sneezing itchy watery eyes itchy nose or throat cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever

Dosage and administration

Age                                                                                  Dose Children under 4 years                                                      Do not use Children 4 to under 12 years of age                                    Do not use unless directed by a doctor Adults and children 12 years and over                                2 tablespoonful (30 mL) every 4 hours take only as recommende...

Label contents#

Full prescribing information#

Drug facts Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each tablespoonful 15 mL)

Acetaminophen 325 mg
Diphenhydramine HCL  12.5 mg
Phenylephrine HCL 5mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant

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 these common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy watery eyes
  • itchy nose or throat
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warnings: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 dose in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Warnings

USER SAFETY WARNINGS SECTION

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

  • 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 taking  a prescription monamine 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
  • with any other drug containing diphenhydramine, even one used on the skin
  • for children under 4 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • the blood thinning drug warfarin
  • sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • 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 or persistent headache. 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.

Overdose warning

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the 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

Age                                                                                  Dose

Children under 4 years                                                      Do not use

Children 4 to under 12 years of age                                    Do not use unless directed by a doctor

Adults and children 12 years and over                                2 tablespoonful (30 mL) every 4 hours

  • take only as recommended (see Overdose warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 6 doses in any 24-hour period

Other information

SPL UNCLASSIFIED SECTION

  • each tablespoon (15 mL) contains:  potassium 9 mg, sodium 6 mg
  • dosage cup provided
  • store between 20°-25° C (68°-7°7 F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

Questions?

OTC - QUESTIONS SECTION

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 6801-154-08

*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION

Premier Value®

Night Time Severe Cold and Cough Relief

Acetaminophen ............ Pain Reliever/Fever Reducer
Diphenhydramine.......... Antihistamine/Cough Suppressant
Phenylephrine HCL ...... Nasal Congestion

    Fever and Body Aches
    Sore Throat
    Headache
    Nasal Congestion
    Runny Nose
    Cough

   Cherry Flavor

8.3 FL OZ (245 mL)

PV  Independently Tested Satisfaction Guaranteed

LF-007

DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences

LB-007

DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431

Lot:
Exp:

*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time


AptaPharma 154-1 LabelAptaPharma 154-1 Label


AptaPharma 154-2 LabelAptaPharma 154-2 Label


AptaPharma154-3 LabelAptaPharma154-3 Label

AptaPharma154-4 LabelAptaPharma154-4 Label


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298348acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN5
1298348acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD5
1298348acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY5
1298348acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY5
1298348APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-154-082020-12-31C16284748780-19d75b9cf-e2ac-f424-e053-dadaa90a57cec8e9b57b-83e9-46c5-9791-02c4c2b94004
68016-154-082020-01-31C16284748780-19d75b9cf-e2ac-f424-e053-dadaa90a57cec8e9b57b-83e9-46c5-9791-02c4c2b94004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-154-08Night Time Severe Cold and Cough Relief245 mL in 1 BOTTLELIQUID2455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-154NIGHT TIME SEVERE COLD AND COUGH RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CHAIN DRUG CONSORTIUM, LLC]5Current NDC, Legacy NDC, 1 package rows20241231_c8e9b57b-83e9-46c5-9791-02c4c2b94004.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-154-08ML - Milliliter68016-154e0cb6fb2-4c63-4c83-9380-9d5f2aedba8d12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
MALTITOLINACTIVE INGREDIENTD65DG142WK1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-15468016-154-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT

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 · 168 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / ORAL197 mgExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii+route
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
38 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii+route
44 equally ranked IID candidates
MALTITOLMALTITOLD65DG142WKSOLUTION / ORAL9000 mgExact identifier — unii+route
10 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+route
38 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii+route
26 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9FILM, SOLUBLE / ORAL10 mgExact identifier — unii+route
26 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / ORAL400 mgExact identifier — unii+route
26 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FILM COATED / ORAL1.75 mgExact identifier — unii+route
26 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SUSPENSION / ORAL160 mgExact identifier — unii+route
26 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii+route
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii+route
26 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii+route
44 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET / ORAL111 mgExact identifier — unii+route
26 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
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
ndc (package): 68016-154-08
ndc (product): 68016-154
ndc11 (package): 68016015408
spl id: 2f8462e8-7096-4688-ba3d-14caae022944
spl set id: c8e9b57b-83e9-46c5-9791-02c4c2b94004

Reported adverse events (FAERS/openFDA)#

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