FDA.reportPublic FDA data

CVS PHARMACY

Manufacturer
CVS PHARMACY
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:47:34

Label at a glance#

ProductCVS PHARMACY Nighttime MS Flu Relief
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and 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

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...

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • 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

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.

Do not use

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 a MAO, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

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 rash or headache that lasts.
  • These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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.
  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. 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 8 oz. of cool water; stir briskly before and after heating. Do not overheat

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains: potassium 6 mg
  • store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, Caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime*

NDC 51316-945-06

Nighttime

Multi-Symptom

Flu Relief

MAX STRENGTH**

Acetaminophen 1000 mg - Pain Reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Dextromethorphan HBr 30 mg - Cough Suppressant

Hot Liquid therapy that relieves:

  • Fever
  • Body ache
  • Headache
  • Sore throat pain
  • Cough

Honey Lemon

Natural & Artificial Flavored

6 PACKAETS

**Maximum Strength per 6 hours dose

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN OR BROKEN.

*This product is not manufactured or distributed by Haleon group, owner of Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime.

Manufactured by:

Nighttime MS Flu relief Max strength 6 Packets
Nighttime MS Flu relief Max strength 6 Packets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral SolutionPSN2
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD2
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY2
2636658APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-945-06CVS PHARMACYNighttime MS Flu Relief1 in 1 PACKETPOWDER, FOR SOLUTION12
51316-945-06CVS PHARMACYNighttime MS Flu Relief6 in 1 CARTONPOWDER, FOR SOLUTION62

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-94551316-945-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARAMELT9D99G2B1RIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-06monthly-update2026-06-03 17:56:15

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PHARMACY Nighttime MS Flu ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY23cafaa1-34fe-4cef-960b-5f664ea32cb42026-02-27WarningsExact identifier
ndc (package): 51316-945-06
ndc (product): 51316-945
ndc11 (package): 51316094506
spl id: a9d254e3-6157-4a0b-bff6-a07ca3aee7ac
spl set id: 23cafaa1-34fe-4cef-960b-5f664ea32cb4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.