FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each extended-release tablet)
Acetaminophen USP 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 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
- skin reddening
- blisters
- rash.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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 tablets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 tablets 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 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF).
- do not use if carton is opened or foil inner seal is broken
- USP Dissolution test is pending
Inactive Ingredients
colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin
Questions or comments?
call 1-855-274-4122
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
Made in India
Code: TS/DRUGS/22/2009
Package Label-Principal Display Panel - 650 Mg (24 Tablets Bottle)
CVSHealth® Tablets
NDC 69842-635-07
8HR Muscle
Aches & Pain
ACETAMINOPHEN
EXTENDED-RELEASE
TABLETS USP, 650 mg
Pain Reliever/Fever Reducer
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
24 EXTENDED-RELEASE
TABLETS 650 mg EACH
Package Label-Principal Display Panel - 650 Mg (24 Tablets Container Carton)
CVS Health® Compare to the active ingredient in
Tylenol® 8HR Muscle Aches & Pain*
Tablets
NDC 69842-635-07
8HR Muscle Aches & Pain
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS USP, 650 mg
Pain Reliever/Fever Reducer
For up to 8 hours of relief of minor
muscle aches & pain
Contains No Aspirin
24 EXTENDED-RELEASE
TABLETS 650 mg EACH
DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN
* Please review the disclaimer below.