Handy Solutions Acetaminophen

Handy Solutions Acetaminophen
SPL v2
SPL
SPL Set ID b2256b2b-76cb-43cd-914c-86a6fe018cb6
Route
ORAL
Published
Effective Date 2016-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Hypromellose, Unspecified Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: FR;33 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-09-21
Description

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 500 mg

Uses

For the temporary relief of minor aches and pains associated with:

• headache • muscular aches • minor arthritis pain • common cold • toothache • menstrual cramps

For the reduction of fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets 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

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years of age: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Do Not Use
  • 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
Other Information
  • Tamper evident. Do not ues if packet is torn, cut or opened
  • Store at controlled room temperatures 15° to 30° C (59 to 86°F)
Package Labeling:

Inactive Ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

*may contain

Questions Or Comments?

call 1-800-525-5097

Stop Use and Ask A Doctor If
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
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.

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 500 mg

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.

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with:

• headache • muscular aches • minor arthritis pain • common cold • toothache • menstrual cramps

For the reduction of fever.

Purpose

Pain Reliever/Fever Reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets 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

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years of age: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Do Not Use (Do not use)
  • 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
Other Information (Other information)
  • Tamper evident. Do not ues if packet is torn, cut or opened
  • Store at controlled room temperatures 15° to 30° C (59 to 86°F)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

*may contain

Questions Or Comments? (Questions or comments?)

call 1-800-525-5097

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
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.

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 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:56.540112 · Updated: 2026-03-14T22:55:45.140912