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
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
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...
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Pain Reliever/fever reducer
Cough suppressant
Nasal decongestant
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
ask a health professional before use.
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.
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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
call 1-855-328-5259
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
ask a health professional before use.
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.
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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
call 1-855-328-5259
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
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.
NDC 0067-7919-12
THERAFLU
MULTI-SYMPTOM SEVERE COLD
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
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
HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS
NIGHTTIME 6 PACKETS
USE AS DIRECTED
12 TOTAL PACKETS
gsk
13469

NDC 0067-8200-01
THERAFLU
MULTI-SYMPTOM SEVERE COLD
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
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
HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS
NIGHTTIME 6 PACKETS
USE AS DIRECTED
24 TOTAL PACKETS
gsk
13471

| RxCUI | RxNorm string | TTY | SPL 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) } Pack | GPCK | 8 |
| 2640034 | 1 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) Pack | PSN | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 8 |
| 2640034 | 1 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) Pack | SY | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 8 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 8 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 8 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-7919-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-54e7-111a-e063-dadaa90a10e2 | Drug Facts |
| 0067-8200-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-54e7-111a-e063-dadaa90a10e2 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-6426-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 500 mg in 237mL | 8 |
| 0067-6426-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 500 mg in 237mL | 8 | |
| 0067-7918-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 650 mg in 237mL | 8 |
| 0067-7918-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 650 mg in 237mL | 8 | |
| 0067-7919-12 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 8 | |
| 0067-6426-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 4266 mL | 500 mg in 237mL | 8 |
| 0067-6426-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 500 mg in 237mL | 8 | |
| 0067-7918-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 650 mg in 237mL | 8 |
| 0067-7918-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 650 mg in 237mL | 8 | |
| 0067-8200-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-6426 | THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC | 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip |
| 0067-7918 | THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC | 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip |
| 0067-7919 | THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC, 5 package rows | 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip |
| 0067-8200 | THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC, 5 package rows | 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-7919-12 | EA - Each | 0067-7919 | c3543916-1f06-4092-a2a0-375e13ce1fd8 | 1 | 2018-04-19 |
| 0067-6426-01 | EA - Each | 0067-6426 | 58cccbc7-1d11-42e3-b3cb-081fe8fafced | 1 | 2020-09-14 |
| 0067-6426-06 | EA - Each | 0067-6426 | c8500b3f-3199-4fa6-8abd-9dd87445b1ac | 1 | 2012-07-24 |
| 0067-7918-01 | EA - Each | 0067-7918 | 53abe691-ab9e-417e-83a4-f095d2857a75 | 1 | 2022-06-06 |
| 0067-7918-06 | EA - Each | 0067-7918 | bd024597-3a48-4bb9-a8d1-15d200f87b95 | 1 | 2014-08-01 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0067-7919 | 0067-7919-12 |
| 0067-6426 | 0067-6426-01, 0067-6426-06 |
| 0067-7918 | 0067-7918-01, 0067-7918-06 |
| 0067-8200 | 0067-8200-01 |
Every source-derived ingredient row is available through these pages.
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.
Adverse event summaries are temporarily unavailable. Other product information remains available.