temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache cough due to minor throat and bronchial irritation temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over 30 mL Children under 12 years of age do not use
www.productpats.com
www.StopMedicineAbuse.orgAcetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Pain reliever/Fever reducer
Cough suppressant
Expectorant
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 a fever, headache, rash, nausea, or vomiting consult a doctor promptly.
These could be signs of a serious condition.
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.
Age | Dose |
Adults and children 12 years of age and over | 30 mL |
Children under 12 years of age | do not use |
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
1-855-328-5259
Distributed by: Haleon, Warren, NJ 07059 Made in Mexico
Trademarks are owned by or licensed to the Haleon group of companies.
©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com
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DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
+ CHEST CONFESTION
Acetaminophen
Pain reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Guaifenesin/ Expectorant
DAYTIME FORMULA
Powerful formula that relieves:
/ Chest congestion
/ Thins and loosens mucus
/ Head and body ache
/ Fever
/ Cough
/ Sore throat pain
8.3 FL OZ (245.5 mL)
Berry Flavor
PARENTS:
Learn about teen medicine abuse
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1042695 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution | PSN | 5 |
| 1042695 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution | SCD | 5 |
| 1042695 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral Solution | SY | 5 |
| 1042695 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution | SY | 5 |
| 1042695 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML Oral Solution | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-0104-08 | TherafluSevere Cold Relief Chest Congestion Daytime | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0067-0104 | 0067-0104-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Theraflu Severe Cold Relief Chest Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | 8c821671-dc68-4e27-aa87-b4e45ade9817 | 2025-11-13 | Warnings | 0067-0104-08 0067-0104 00067010408 438018c4-8730-1a2d-e063-6294a90a4c46 8c821671-dc68-4e27-aa87-b4e45ade9817 |
| Theraflu Severe Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN | Haleon US Holdings LLC | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 2024-10-14 | Warnings | 0067-0104-08 00067010408 |
Adverse event summaries are temporarily unavailable. Other product information remains available.