Drug Facts
Active ingredient (in each extended-release tablet)
Acetaminophen USP 650 mg
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Acetaminophen (NDC 21130-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each extended-release tablet)
Acetaminophen USP 650 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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.
Adults:
Under 18 years of age:
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
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASONTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com
MADE IN INDIA
CODE: TS/DRUGS/22/2009
TO OPEN:
1. PUSH DOWN
2. TURN CAP
Signaturte
Care®
Quality
Guaranteed
DO NOT USE
WITH OTHER
MEDICINES
CONTAINING
ACETAMINOPHEN
8 HOUR NDC 21130-108-35
ARTHRITIS
PAIN
RELIEVER
ACETAMINOPHEN
Extended-Release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the temporary relief of 225
minor arthritis pain Extended-Release
Tablets
Compare to Tylenol®8HR Arthritis Pain
active ingredient*
NDC 21130-108-35
Signature
Care®
Quality Guaranteed
DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN
8 HOUR
ARTHRITIS
PAIN RELIEVER
ACETAMINOPHEN Actual Size
Extended-Release 06
Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the temporary relief 225
of minor arthritis pain Extended-release
tablets
* Please review the disclaimer below.