FDA.reportPublic FDA data

DRX CHOICE

Manufacturer
Raritan Pharmaceuticals Inc.
Effective date
2026-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:22

Label at a glance#

ProductDRX CHOICE NIGHTTIME COLD and FLU RELIEF
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure11 sections

Indications and uses

temporarily relieves common cold/flu symptoms: ▪ cough due to minor throat & bronchial irritation ▪ sore throat ▪ headache ▪ minor aches & pains ▪ fever ▪ runny nose & sneezing

Dosage and administration

▪ take only as directed ▪ do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

Warnings

WARNINGS SECTION

  • 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

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

  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

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.

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.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 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
  • do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, D&C Yellow No. 10, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

SPL UNCLASSIFIED SECTION

Distributed by:
Raritan Pharmaceuticals
8 Joanna Court

East Brunswick, NJ 08816

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu LiquiCaps™

DRx Choice®

Nighttime

Cold & flu relief

Acetaminophen – Pain Reliever/Fever Reducer

Doxylamine Succinate – Antihistamine

Dextromethorphan HBr – Cough Suppressant

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

10 softgels

DRx Choice nighttime cold & flu relief 10 softgels
DRx Choice nighttime cold & flu relief 10 softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN1
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD1
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368163062106GTIN-13: 0368163062106
EAN-13: 0368163062106
GTIN-12: 368163062106
UPC-A: 368163062106
GTIN storage (14 digits): 00368163062106		995.jpg
Data codeITF01255912995.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-062-10DRX CHOICENIGHTTIME COLD and FLU RELIEF5 in 1 CARTONCAPSULE, LIQUID FILLED51
68163-062-10DRX CHOICENIGHTTIME COLD and FLU RELIEF2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED21

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
68163-06268163-062-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
DRX CHOICE NIGHTTIME COLD and FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATERaritan Pharmaceuticals Inc.f466fc0e-3384-4884-832e-99bf1fdcf8992026-01-21WarningsExact identifier
ndc (package): 68163-062-10
ndc (product): 68163-062
ndc11 (package): 68163006210
spl id: f466fc0e-3384-4884-832e-99bf1fdcf899
spl set id: f466fc0e-3384-4884-832e-99bf1fdcf899

Reported adverse events (FAERS/openFDA)#

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