Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:10:56

Label at a glance#

ProductTheraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure19 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to...

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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: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

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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 an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • 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 out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. do not use
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains:potassium 10 mg, sodium 19 mg
  • phenylketonurics:contains phenylalanine 20 mg per packet
  • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-328-5259

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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: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

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • 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 product containing diphenhydramine, even one used on the skin
  • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • 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 out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. do not use
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains:potassium 10 mg, sodium 23 mg
  • phenylketonurics:contains phenylalanine 13 mg per packet
  • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-328-5259

Additional Information

SPL UNCLASSIFIED SECTION

DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER-EVIDENT INNER UNIT.

DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

1-855-328-5259

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

©2019 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF MULTI-SYMPTOM PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-7919-12

THERAFLU

MULTI-SYMPTOM SEVERE COLD

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body Ache
  • Fever

TEA INFUSIONS

GREEN TEA & HONEY LEMON FLAVORS

MULTI-SYMPTOM 6 PACKETS

NIGHTTIME

SEVERE COLD & COUGH

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body Ache
  • Fever
  • Runny Nose
  • Sneezing

HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS

NIGHTTIME 6 PACKETS

USE AS DIRECTED

12 TOTAL PACKETS

gsk

13469

Theraflu Multi-Symptom Severe Cold and Night Severe Cold & Cough copack 12 count carton.
Theraflu Multi-Symptom Severe Cold and Night Severe Cold & Cough copack 12 count carton.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-8200-01

THERAFLU

MULTI-SYMPTOM SEVERE COLD

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body Ache
  • Fever

TEA INFUSIONS

GREEN TEA & HONEY LEMON FLAVORS

MULTI-SYMPTOM 18 PACKETS

NIGHTTIME

SEVERE COLD & COUGH

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body Ache
  • Fever
  • Runny Nose
  • Sneezing

HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS

NIGHTTIME 6 PACKETS

USE AS DIRECTED

24 TOTAL PACKETS

gsk

13471

Theraflu Multi-Symptom Severe Cold and Nighttime Severe Cold & Cough copack 24 count carton
Theraflu Multi-Symptom Severe Cold and Nighttime Severe Cold & Cough copack 24 count carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2640034{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } PackGPCK8
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackPSN8
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN8
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN8
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD8
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD8
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackSY8
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY8
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY8
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY8
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY8
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY8
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY8

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-7919-122024-01-30C16284748780-11030e365-54e7-111a-e063-dadaa90a10e2Drug Facts
0067-8200-012024-01-30C16284748780-11030e365-54e7-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6426-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL500 mg in 237mL8
0067-6426-06Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION500 mg in 237mL8
0067-7918-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL650 mg in 237mL8
0067-7918-06Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION650 mg in 237mL8
0067-7919-12Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough1 in 1 PACKAGE, COMBINATIONKIT18
0067-6426-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough237 mL in 1 PACKETPOWDER, FOR SOLUTION4266 mL500 mg in 237mL8
0067-6426-06Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION500 mg in 237mL8
0067-7918-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough237 mL in 1 PACKETPOWDER, FOR SOLUTION1422 mL650 mg in 237mL8
0067-7918-06Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION650 mg in 237mL8
0067-8200-01Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough1 in 1 PACKAGE, COMBINATIONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6426THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip
0067-7918THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip
0067-7919THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 5 package rows20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip
0067-8200THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 5 package rows20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-7919-12EA - Each0067-7919c3543916-1f06-4092-a2a0-375e13ce1fd812018-04-19
0067-6426-01EA - Each0067-642658cccbc7-1d11-42e3-b3cb-081fe8fafced12020-09-14
0067-6426-06EA - Each0067-6426c8500b3f-3199-4fa6-8abd-9dd87445b1ac12012-07-24
0067-7918-01EA - Each0067-791853abe691-ab9e-417e-83a4-f095d2857a7512022-06-06
0067-7918-06EA - Each0067-7918bd024597-3a48-4bb9-a8d1-15d200f87b9512014-08-01

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 56 matching rows.

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCb06b64c5-dbb4-4ef5-af18-3d7d4979c02f2024-04-10WarningsExact identifier
ndc (package): 0067-7919-12
ndc (package): 0067-8200-01
ndc (package): 0067-6426-01
ndc (package): 0067-6426-06
ndc (package): 0067-7918-01
ndc (package): 0067-7918-06
ndc (product): 0067-7919
ndc (product): 0067-8200
ndc11 (package): 00067791806
ndc11 (package): 00067642601
ndc11 (package): 00067642606
ndc11 (package): 00067820001
ndc11 (package): 00067791912
ndc11 (package): 00067791801
spl id: 15bf1214-572a-f6b6-e063-6394a90ab0cb
spl set id: b06b64c5-dbb4-4ef5-af18-3d7d4979c02f
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact identifier
ndc (package): 0067-6426-01
ndc (package): 0067-6426-06
ndc (product): 0067-6426
ndc11 (package): 00067642601
ndc11 (package): 00067642606
THERAFLU NIGHTTIME SEVERE COLD AND COUGHACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC5f7f6f70-0f36-4541-89f2-d953259cdb1e2024-01-28WarningsExact identifier
ndc (package): 0067-7918-01
ndc (package): 0067-7918-06
ndc (product): 0067-7918
ndc11 (package): 00067791806
ndc11 (package): 00067791801

Reported adverse events (FAERS/openFDA)#

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