Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate

Manufacturer
CVS Pharmacy, Inc
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:39:46

Label at a glance#

ProductAcetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure4 sections

Label contents#

Full prescribing information#

Day Time Powder

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each packet)
Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to a common cold or flu:
• minor aches and pains • minor sore throat pain • headache
• cough due to minor throat and bronchial irritation
• 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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not use more than directed.

OTC - STOP USE SECTION

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 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

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed
• take every 6 hours, while symptoms persist
• Do not take more than 4 packets in 24 hours unless directed by a doctor
• 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.

AgeDose
adults and children 12 years
of age and over
one packet
children under 12 years of agedo not use

Other information

OTHER SAFETY INFORMATION

• each packet contains: sodium 6 mg, potassium 10 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).

INACTIVE INGREDIENT SECTION

acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C blue #1, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin,
sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.

Nighttime Powder

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each packet)
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

OTC - PURPOSE SECTION

Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to a common cold or flu:
• minor aches and pains • minor sore throat pain
• headache • runny nose • cough due to minor throat and bronchial irritation
• 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

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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product
• do not exceed recommended dosage

• 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

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 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

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed
• take every 6 hours, while symptoms persist
• Do not take more than 4 packets in 24 hours unless directed by a doctor

• 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.

AgeDose
adults and children 12 years
of age and over
one packet
children under 12 years of agedo not use

Other information

OTHER SAFETY INFORMATION

• each packet contains: sodium 6 mg, potassium 10 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).

INACTIVE INGREDIENT SECTION

acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin, sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.

OTC - QUESTIONS SECTION

Questions? 1-800-231-4670

Draft Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS LabelCVS Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2636659{1 (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } PackGPCK2
2636659{1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } PackPSN2
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral SolutionPSN2
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionPSN2
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD2
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD2
2636659{1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) } PackSY2
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY2
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY2
2636658APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY2
2636656APAP 1000 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
51316-604-05Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate6 in 1 PACKETPOWDER6 in 1230 mg2
51316-605-05Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate6 in 1 PACKETPOWDER6 in 124 mg2
51316-609-07Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate1 in 1 CARTONKIT12

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-60951316-609-07
51316-60451316-604-05
51316-60551316-605-05

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-04-03full-release2026-06-01 00:10:47

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
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine MaleateACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATECVS Pharmacy, Inc1532ee21-e114-ded7-e063-6294a90ab0252025-10-21WarningsExact identifier
ndc (package): 51316-605-05
ndc (package): 51316-604-05
ndc (package): 51316-609-07
ndc (product): 51316-609
ndc11 (package): 51316060907
ndc11 (package): 51316060405
ndc11 (package): 51316060505
spl id: 41b206d7-e021-f8e0-e063-6394a90ad0e1
spl set id: 1532ee21-e114-ded7-e063-6294a90ab025

Reported adverse events (FAERS/openFDA)#

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