Indications and uses
▪ temporarily relieves these symptoms due to a common cold: ▪ headache ▪ minor aches and pains ▪ cough due to minor throat and bronchial irritation ▪ minor sore throat pain ▪ temporarily reduces fever
Theraflu Multi-Symptom flu Relief Daytime Drug facts
- Manufacturer
- CVS PHARMACY
- Effective date
- 2026-08-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:02:05
Label at a glance#
ProductTheraflu Relief Max Strength Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Dosage and administration
• do not use more than directed • take every 6 hours, while symptoms persist • do not take more than 3 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 the entire drink within 10-15 minutes. ▪ if using a microwave, add c...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (each packet)
Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg
Purposes
Pain reliever/Fever reducer
Cough suppressant
Uses
- temporarily relieves these symptoms due to a common cold:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- temporarily reduces fever
Warnings
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
- 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
- liver disease
- 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
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage.
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
- These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- take every 6 hours, while symptoms persist
- do not take more than 3 packets in 24 hours unless directed by a doctor
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- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume the entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: sip briskly before and after heating.
- do not overheat.
Other information
- each packet contains: potassium 6 mg
- store at room temperature. Protect from excessive heat and moisture.
Inactive ingredients
anhydrous citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose
Questions or comments?
1-866-467-2748
Principal Display Panel
*Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Daytime
NDC 51316-539-06
Daytime
Flu Relief
MAX STRENGTH**
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Honey Lemon Flavor
1 SINGLE DOSE
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Flu Relief Max Strength** Daytime.
**Maximum Strength per 6 hour dose
Manufactured by:
Raritan Pharmaceuticals,
8 Joanna Court, East Brunswick, NJ 08816
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Theraflu Relief Max Strength Daytime
- Acetaminophen, Dextromethorphan HBr
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ANHYDROUS CITRIC ACID
- CARAMEL
- MALTODEXTRIN
- POTASSIUM CHLORIDE
- SILICON DIOXIDE
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-539 | 51316-539-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARAMEL | T9D99G2B1R | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POTASSIUM CHLORIDE | 660YQ98I10 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-12-08 | full-release | 2026-06-01 01:20:41 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Theraflu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 932a3d40-9b52-4e91-bc61-6fd506f2d9e6 | 2026-08-14 | Warnings | 51316-539-06 51316-539 51316053906 bd0708e4-2289-4f13-859b-18a741f328d8 932a3d40-9b52-4e91-bc61-6fd506f2d9e6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.