Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr
- Manufacturer
- CVS Pharmacy, Inc
- Effective date
- 2025-09-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:12:33
Label at a glance#
ProductAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure4 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Daytime Flu Relief Maximum Strength
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Dextromethorphan HBr 15 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/Fever reducer
Cough suppressant
Uses
- temporarily relieves these symptoms due to a common cold or flu:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- temporarily reduces fever
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.
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.
OTC - ASK DOCTOR SECTION
- 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
OTC - ASK DOCTOR/PHARMACIST SECTION
- taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not use more than directed.
OTC - STOP USE SECTION
- 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 a rash or headache that lasts
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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
- adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
- do not take more than 6 caplets in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use
Other information
Store in a dry place at 15º - 30°C (59° -86°F).
INACTIVE INGREDIENT SECTION
corn starch, crospovidone, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, medium chain triglycerides,
microcrystalline cellulose, mineral oil, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide.
OTC - QUESTIONS SECTION
1-800-231-4670
SPL UNCLASSIFIED SECTION
Nighttime Flu Relief Maximum Strength
Drug facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 15 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Uses
- temporarily relieves these symptoms due to a common cold or flu:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- runny nose
- temporarily reduces fever
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.
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.
OTC - ASK DOCTOR SECTION
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- 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
OTC - ASK DOCTOR/PHARMACIST SECTION
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
- 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
OTC - STOP USE SECTION
- 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 a rash or headache that lasts
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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
- adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
- do not take more than 6 caplets in 24 hours unless directed by a doctor
- children under 12 years of age: do not use
| Age | Dose |
| adults and children 12 years of age and over | 2 caplets every 6 hours |
| children under 12 years of age | do not use |
Other information
Store in a dry place at 15° – 30°C (59° – 86°F).
INACTIVE INGREDIENT SECTION
corn starch, crospovidone, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.
OTC - QUESTIONS SECTION
1-800-231-4670
SPL UNCLASSIFIED SECTION
*CVS™ is not affiliated with the owner of the registered trademark Theraflu® Flu Relief Max Strength Daytime & Nighttime.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
TAMPER EVIDENT FEATURE: FLU RELIEF MAX STRENGTH CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER
THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CVS™
NDC 51316-984-03
Compare to Theraflu® Flu Relief Max Strength Daytime & Nighttime active ingredients*
Maximum Strength†
DAYTIME FLU RELIEF
Acetaminophen
Pain Reliever, Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Relieves: Fever, Body aches, Headache, Sore throat pain, Cough
20 DAYTIME CAPLETS
Maximum Strength†
NIGHTTIME FLU RELIEF
Acetaminophen
Pain Reliever, Fever Reducer
Chlorpheniramine Maleate,
Antihistamine
Dextromethorphan HBr
Cough Suppressant
Additional Nighttime Relief of: Runny nose
20 NIGHTTIME CAPLETS
40 TOTAL CAPLETS
†Maximum Strength per 6 hour dose under OTC monograph.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2604579 | {1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) } Pack | GPCK | 2 |
| 2604579 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) Pack | PSN | 2 |
| 1098496 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet | PSN | 2 |
| 247324 | acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet | PSN | 2 |
| 1098496 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SCD | 2 |
| 247324 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SCD | 2 |
| 2604579 | 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) Pack | SY | 2 |
| 247324 | acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet | SY | 2 |
| 1098496 | APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SY | 2 |
| 247324 | APAP 500 MG / Dextromethorphan Hydrobromide 15 MG Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-451-01 | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 20 in 40 | 500 mg | 2 |
| 51316-983-01 | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 20 in 40 | 500 mg | 2 |
| 51316-984-03 | Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | 1 in 1 CARTON | KIT | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CROSPOVIDONE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C BLUE NO. 2 ALUMINUM LAKE
- HYPROMELLOSES
- MAGNESIUM STEARATE
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A
- STEARIC ACID
- ACETAMINOPHEN
- STARCH, CORN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- TITANIUM DIOXIDE
- MICROCRYSTALLINE CELLULOSE
- TRIACETIN
- MINERAL OIL
- Acetaminophen, Dextromethorphan HBr
- MEDIUM-CHAIN TRIGLYCERIDES
- TALC
- POLYDEXTROSE
- FD&C RED NO. 40 ALUMINUM LAKE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-984 | 51316-984-03 |
| 51316-451 | 51316-451-01 |
| 51316-983 | 51316-983-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS Pharmacy, Inc | 31aa77e0-cfdb-57a8-e063-6394a90af98c | 2025-09-04 | Warnings | 51316-984-03 51316-983-01 51316-451-01 51316-984 51316045101 51316098301 51316098403 3dfcf55b-f354-d770-e063-6294a90ad124 31aa77e0-cfdb-57a8-e063-6394a90af98c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.