DailyMed - 8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

NDC Code(s): 69842-764-78
Packager: CVS Pharmacy

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 9, 2020

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Active ingredient (in each caplet)
Acetaminophen 650 mg

Acetaminophen 650 mg
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Purpose
Pain reliever/fever reducer

Pain reliever/fever reducer
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Uses
• temporarily relieves minor aches and pains due to: • muscular aches - • backache - • minor pain of arthritis - • toothache - • premenstrual and menstrual cramps - • headache - • the common ...

•

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

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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 ...

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.

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.

•

if you are allergic to acetaminophen or any of the inactive ingredients in this product

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

•

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.

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If pregnant or breast-feeding,
ask a health professional before use.

ask a health professional before use.
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Keep out of reach of children.
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 ...

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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Directions

• 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 ...

Other information
• store at 20-25°C (68-77°F) • do not use if printed foil under cap is broken or missing - • meets the requirements of USP Dissolution Test 2

•

store at 20-25°C (68-77°F)

•

do not use if printed foil under cap is broken or missing

•

meets the requirements of USP Dissolution Test 2

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Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone ...

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide
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Questions or comments?
1-800-719-9260

1-800-719-9260
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Package/Label Principal Display Panel
Compare to the active ingredient in Tylenol® 8HR - Caplets† 8HR Muscle Aches & Pain - ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 mg - Pain Reliever/Fever Reducer - For up to 8 hours relief of minor ...

Compare to the active ingredient in Tylenol® 8HR

Caplets†

8HR Muscle Aches & Pain

ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 mg

Pain Reliever/Fever Reducer

For up to 8 hours relief of minor muscle aches & pain

100 CAPLETS†, 650 mg EACH

†CAPSULE-SHAPED TABLETS

Actual Size

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INGREDIENTS AND APPEARANCE

Product Information

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	RxCUI	RxNorm NAME	RxTTY
1	1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN
2	1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD
3	1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY
4	1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY

Label: 8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

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 • do not use for more than 10 days unless directed by a doctor
children under 12 years	• do not use

Label: 8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

Number of versions: 1

8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

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8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, film coated, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.