Acetaminophen, Dextromethorphan HBr

Manufacturer
NUVICARE LLC
Effective date
2026-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-08 02:02:06

Label at a glance#

ProductAcetaminophen, Dextromethorphan HBr
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure18 sections

Indications and uses

Temporarily relieves common cold and flu symptoms: • Minor aches and pains • Headache • Sore throat • Fever • Cough due to minor throat and bronchial irritation

Dosage and administration

Take only as directed-see OVERDOSE WARNING. Do not exceed 8 softgels per 24 hours.  Adults & children 12 years and over  Take 2 softgels with water every 4 hours  Children 4 to under 12 years  Ask a doctor  Children under 4 years  Do not use

Label contents#

Full prescribing information#

Active Ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg ........................................ Pain reliever/fever reducer

Dextromethorphan HBr 10 mg ......................... Cough suppressant

Purpose

OTC - PURPOSE SECTION

Acetaminophen 325 mg ........................................ Pain reliever/fever reducer

Dextromethorphan HBr 10 mg ......................... Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold and flu symptoms:
• Minor aches and pains
• Headache
• Sore throat
• Fever
• Cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

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.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:
• More than 8 softgels in 24 hours, which is the maximum daily amount for this product
• With other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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
• With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use 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
• diabetes
• heart disease
• thyroid disease
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

OTC - WHEN USING SECTION

When using this product
• Do not exceed recommended dosage.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if
• Pain, cough, or nasal congestion gets worse or lasts more than 7 days.
• New symptoms occur.
• Nervousness, dizziness, or sleeplessness occur.
• Fever gets worse or lasts more than 3 days.
• Redness or swelling is present.
• Cough comes back or occurs with 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 health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OVERDOSAGE SECTION

Overdose warning: 
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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

Take only as directed-see OVERDOSE WARNING.
Do not exceed 8 softgels per 24 hours.

 Adults & children 12 years and over Take 2 softgels with water every 4 hours
 Children 4 to under 12 years Ask a doctor
 Children under 4 years Do not use

Other information

OTHER SAFETY INFORMATION

• Store at room temperature between 20°–25°C (68°–77°F).
• Avoid excessive heat, cold, and humidity.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Polyethylene Glycol-400, Propylene Glycol, Povidone (PVPK-30), FD & C Red No. 40, FD & C Yellow No. 6, Purified Water, Gelatin, Glycerin, Sorbitol Sorbitan Solution.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or email: support@nuvicare.com

NDC 84324-036-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAYTIME COLD & FLU (2)DAYTIME COLD & FLU (2)

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130384324000190GTIN-13: 0384324000190
EAN-13: 0384324000190
GTIN-12: 384324000190
UPC-A: 384324000190
GTIN storage (14 digits): 00384324000190
DAYTIME COLD & FLU (2).jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-03684324-036-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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 HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
ndc (package): 84324-036-01
ndc (product): 84324-036
ndc11 (package): 84324003601
spl id: c0e2d2ac-5795-4be8-8339-bfae50456e24
spl set id: 6713fdff-0e4e-4a9d-b218-34f786339c57

Reported adverse events (FAERS/openFDA)#

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