Only For

Only For
SPL v1
SPL
SPL Set ID bd4d089c-3953-4b49-9df6-e8722eec4418
Route
ORAL
Published
Effective Date 2019-05-13
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 Yellow No. 6 Fd&c Blue No. 2 Gelatin, Unspecified Magnesium Palmitostearate Starch, Corn Microcrystalline Cellulose 101 Polyethylene Glycol 400 Polyvinyl Alcohol (94000 Mw) Water Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-29
Description

Acetaminophen 500mg Caffeine 65mg

Purpose

Pain reliever Pain reliever aid

Medication Information

Purpose

Pain reliever

Pain reliever aid

Description

Acetaminophen 500mg Caffeine 65mg

Uses:
  • Temporarily relieves minor aches and pains due to:
  • headache      • muscular aches
Section 42229-5

NDC: 73006-110-41

ADULT

ANALGESIC(PAIN RELIEVER)

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.



TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.



Tear along perforation push product through foil

Packaging

Warnings:

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

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. 

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 heart beat. 

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
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if

you have liver disease

Ask a doctor or pharmacist before use if,

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• any new symptoms occur     • 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.

Drug Facts

Directions:
  • take with a full glass of water
  • do not take more than directed
  • do not take more than 6 caplets in 24 hours
 adults and children 12 years of age and over  take 2 caplets every 6 hours, not more than 6 caplets in 24 hours.
 under 12 years of age  ask a doctor

Other Information:
  • Store at room temperature between 20-25°C (68-77°F).
Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, purified water, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Keep Out of Reach of Childern

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet)

Acetaminophen 500mg

Caffeine 65mg

Structured Label Content

Uses:
  • Temporarily relieves minor aches and pains due to:
  • headache      • muscular aches
Section 42229-5 (42229-5)

NDC: 73006-110-41

ADULT

ANALGESIC(PAIN RELIEVER)

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.



TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.



Tear along perforation push product through foil

Purpose

Pain reliever

Pain reliever aid

Packaging

Warnings:

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

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. 

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 heart beat. 

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
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if

you have liver disease

Ask a doctor or pharmacist before use if,

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• any new symptoms occur     • 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.

Drug Facts (DRUG FACTS)

Directions:
  • take with a full glass of water
  • do not take more than directed
  • do not take more than 6 caplets in 24 hours
 adults and children 12 years of age and over  take 2 caplets every 6 hours, not more than 6 caplets in 24 hours.
 under 12 years of age  ask a doctor

Other Information:
  • Store at room temperature between 20-25°C (68-77°F).
Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, purified water, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Keep Out of Reach of Childern (Keep out of reach of childern)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500mg

Caffeine 65mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:48.699254 · Updated: 2026-03-14T22:55:33.121473