OTC Medication Information: 8HR Muscle Aches and Pain

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

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

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.

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.

If pregnant or breast-feeding,

ask a health professional before use.

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 if you do not notice any signs or symptoms.

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 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

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

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

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 muscle aches & pain

100 CAPLETS , 650 mg EACH

CAPSULE-SHAPED TABLETS

Actual Size

8 hr muscle aches and pain image
(click image for full-size original)
8HR MUSCLE ACHES AND PAIN
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-764
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code L544
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-764-78 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (69842-764-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 01/09/2020
Labeler — CVS Pharmacy (062312574)

Revised: 01/2020 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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