REGULAR STRENGTH PAIN RELIEF

Generic name: ACETAMINOPHEN

SPIRIT PHARMACEUTICALS LLC

Dosage Form

N/A

Manufacturer

SPIRIT PHARMACEUTICALS LLC

Active ingredient

ACETAMINOPHEN325 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
temporarily reduces fever

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor
children 6-11 years	take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

68210-0120-1

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (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.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
SPIRIT PHARMACEUTICALS LLC.

RONKONKOMA, NY 11779

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Active ingredient

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Do not use if…Keep out of reach of children.

Ask a doctor before use if…pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These…

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and talk to a doctor if…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 allergic to acetaminophen or any of the in…

Storage and handlingstore between 20-25°C (68-77°F)

Package labelVALUMEDS ™ COMPARE to the active ingredient in REGULAR STRENGTH TYLENOL®* REGULAR STRENGTH PAIN RELIEF Acetaminophen 325 mg PAIN RELIEVER/FEVER REDUCER 10 softgels Actual Size

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Liver warning

Allergy alert

Overdose warning

SPL UNCLASSIFIED SECTION

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