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 ▪ runny nose ▪ temporarily reduces fever
Theraflu Nighttime Flu Relief Max Strength 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 02:02:46
Label at a glance#
ProductTheraflu Relief Max Strength Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
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 entire drink within 10-15 minutes. ▪ if using a microwave, add conte...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each packet)
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Purposes
Pain reliever/Fever reducer
Antihistamine
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
- runny nose
- 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 a MAO, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- 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
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- 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
- 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. 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 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
- each packet contains: potassium 6 mg
- store at room temperature. Protect from excessive heat and moisture.
Inactive ingredients
anhydrous citric acid, Caramel, flavor, 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** Nighttime
NDC 51316-549-06
Nighttime
Flu Relief
MAX STRENGTH**
Acetaminophen Pain Reliever/Fever Reducer
Chlorpheniramine Maleate Antihistamine
Dextromethorphan HBr Cough Suppressant
Honey Lemon
Natural & Artificial Flavored
1 SINGLE DOSE
TO OPEN: CUT ALONG DOTTED LINE WITH SCISSORS DO NOT USE IF SEALED PACKET IS TORN OR BROKEN
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime.
**Maximum Strength per 6 hours 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 Nighttime
- Acetaminophen, Chlorpheniramine Maleate and Dextromethophan HBr
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- ANHYDROUS CITRIC ACID
- CARAMEL
- MALTODEXTRIN
- POTASSIUM CHLORIDE
- SILICON DIOXIDE
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-549 | 51316-549-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | 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 01:20:39 |
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 Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 4b567234-1da9-4e10-a427-877eea2be1c1 | 2026-08-14 | Warnings | 51316-549-06 51316-549 51316054906 886c356e-8c85-40c3-a154-ce68fa85d0d9 4b567234-1da9-4e10-a427-877eea2be1c1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.