FDA.reportPublic FDA data

acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY | Medgel Private Limited
Effective date
2023-03-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:34

Label at a glance#

Productacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation nasal congestion sore throat headache minor aches/pains fever

Dosage and administration

take only as recommended - see OVERDOSE warning do not exceed 6 doses per 24 hours Adults and children 12 years of age and older 2 LiquiCaps with water every 4 hours Children under 12 years of age ask doctor W hen using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Storage and handling

store at room temperature 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purose

OTC - PURPOSE SECTION

  • Pain reliever/ fever reducer
  • Cough suppressant
  • Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • nasal congestion
  • sore throat
  • headache
  • minor aches/pains
  • fever

WARNINGS SECTION

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

OTC - DO NOT USE SECTION

  • with other medicines containing acetaminophen
  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product, do not use more than directed.

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as recommended - see OVERDOSE warning
  • do not exceed 6 doses per 24 hours
Adults and children 12 years of age and older2 LiquiCaps with water every 4 hours
Children under 12 years of ageask doctor

When using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Other Information

STORAGE AND HANDLING SECTION

  • store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules

Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg,
Phenylephrine Hydrochloride USP 5mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-012-
EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.


CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

Shipper LabelShipper Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-012-012025-01-30C16284748780-1f386c64a-24e5-0266-e053-dadaa90a7c1aDayTime Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg)
55629-012-012023-03-25C16284748780-1f386c64a-24e5-0266-e053-dadaa90a7c1aDayTime Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg)
55629-012-012023-01-30C16284748780-1f386c64a-24e5-0266-e053-dadaa90a7c1aDayTime Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-012-01acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride48 in 1 CARTONCAPSULE, LIQUID FILLED482
55629-012-02acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride300 in 1 POUCHCAPSULE, LIQUID FILLED3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-012ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]2Legacy NDC, 2 package rows20230326_841dcd0c-381c-4041-aae7-5609573e82d2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-01255629-012-02, 55629-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE K30U725QWY32XIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

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
c241475a-30cb-4d0b-8b46-cb19a013ad05841dcd0c-381c-4041-aae7-5609573e82d22023-03-25WarningsExact identifier
spl id: c241475a-30cb-4d0b-8b46-cb19a013ad05
spl set id: 841dcd0c-381c-4041-aae7-5609573e82d2

Reported adverse events (FAERS/openFDA)#

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