8HR Muscle Aches and Pain

Generic name: Acetaminophen

AAA Pharmaceutical, Inc.

Dosage Form

N/A

Manufacturer

AAA Pharmaceutical, Inc.

Active ingredient

ACETAMINOPHEN650 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:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
temporarily reduces fever

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	do not use

What it looks like

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

Package codes (NDC)

57344-201-03

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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.

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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 fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if you aretaking 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) retain carton for complete product information and warnings

Package labelRestore U NDC 57344-201-03 †COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® 8HR MUSCLE ACHES AND PAIN 8HR Muscle Aches & Pain Acetaminophen Extended-Release Tablets, 650mg Pain Reliever / Fever Reducer For up to 8 hour reli…