FDA.reportPublic FDA data

DRX CHOICE

Manufacturer
Raritan Pharmaceuticals Inc.
Effective date
2025-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:04

Label at a glance#

ProductDRX CHOICE Tension Headache
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pain due to: headache muscular aches

Dosage and administration

do not use more than directed adults and children 12 years and over : take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years : ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches

Warnings

WARNINGS SECTION

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

WARNINGS SECTION

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning:

WARNINGS SECTION

  • This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Caffeine warning:

WARNINGS SECTION

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

OTC - DO NOT USE SECTION

  • 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.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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. 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

  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • close cap tightly after use
  • read all product information before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27, FD&C blue no. 2, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Excedrin® Tension Headacheactive ingredients *

NDC 68163-506-15

DRx Choice

tension headache

relief

ASPIRIN-FREE

Acetaminophen 500 mg,Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

15 CAPLETS

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.

IMPORTANT:Keep this carton for future reference on full labeling.

Distributed by: Raritan Pharmaceuticals

8 Joanna Court

East Brunswick, NJ 08816

*This product is not manufactured or distributed by Haleon CH Sarl., owner of the registered trademark Excedrin Tension Headache.

DRx Choice Tension Headache Relief 15 caplets
DRx Choice Tension Headache Relief 15 caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN1
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD1
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-506-15DRX CHOICETension Headache1 in 1 CARTONTABLET, FILM COATED11
68163-506-15DRX CHOICETension Headache15 in 1 BOTTLETABLET, FILM COATED151

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68163-50668163-506-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB

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 Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
ndc (package): 68163-506-15
ndc (product): 68163-506
ndc11 (package): 68163050615
spl id: 377780a5-9495-2c39-e063-6294a90ac8b2
spl set id: 8a5cb38b-669d-4177-b33b-d73c7ef48d18

Reported adverse events (FAERS/openFDA)#

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