Other
Drug Facts
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009
Acetaminophen
FDA Label NDC 21130-760
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway Inc. for the product Acetaminophen (NDC 21130-760). 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 other, active ingredient (in each caplet), purpose, uses, liver warning, allergy alert, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Caplet)
Acetaminophen USP, 650 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
- temporarily reduces fever
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.
Otc - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Ask Doctor/Pharmacist
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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)
- 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
- ask a doctor
| adults | |
| under 18 years of age |
Other Information
- store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
- see end panel for batch number and expiration date
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
Questions?
call 1-800-406-7984
Principal Display Panel - 650 Mg Tablet Bottle Carton
NDC 21130-760-05
Signature
care™
Quality Guaranteed
Last up to 8 Hours
Arthritis
Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Use only as directed.
Pain Reliever/Fever Reducer
- For the temporary relief of
minor arthritis pain
COMPARE TO
Tylenol®
Arthritis Pain
active ingredient†
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
50 CAPLETS*
(*Capsule-Shaped Tablets)
Principal Display Panel (650 mg Tablet Bottle Carton)
* Please review the disclaimer below.
