Drx Choice Tension Headache Relief Drug Facts

Drx Choice Tension Headache Relief Drug Facts
SPL v1
SPL
SPL Set ID 8a5cb38b-669d-4177-b33b-d73c7ef48d18
Route
ORAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Fd&c Blue No. 2 Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Eicosyl Povidone Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RP065 Shape: oval Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-16

Description

Acetaminophen 500 mg Caffeine 65 mg

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

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

Pain reliever

Pain reliever aid

Directions
  • 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
Do Not Use
  • 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.
Liver Warning:
  • 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:

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.

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

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?

1-866-467-2748

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.

Ask A Doctor Before Use If
  • you have liver disease
Stop Use and Ask A Doctor If
  • 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,

ask a health professional before use.

Keep Out of Reach of Children.

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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
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.


Structured Label Content

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

Pain reliever

Pain reliever aid

Directions
  • 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
Do Not Use (Do not use)
  • 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.
Liver Warning: (Liver warning:)
  • 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: (Caffeine warning:)

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.

Other Information (Other information)
  • store at room temperature
  • close cap tightly after use
  • read all product information before using.
Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

1-866-467-2748

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.

Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have liver disease
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Caffeine 65 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
Allergy Alert: Acetaminophen May Cause Severe Skin Reactions. Symptoms May Include: (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.


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