Active Ingredient (In Each Caplet)
Acetaminophen USP, 650 mg
Acetaminophen
FDA Label NDC 37808-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H-e-b for the product Acetaminophen (NDC 37808-333). 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 active ingredient (in each caplet), purpose, uses, warnings, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Warnings
Liver warning: This product contains acetaminophen. Sever 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
- 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 | ▪ take 2 caplets every 8 hours with water. |
under 18 years of age | ▪ ask a doctor |
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
Contains No Aspirin
Keep the carton.
It contains important information.
MADE WITH PRIDE & CARE FOR H-E-B
SAN ANTONIO, TX 78204
5108051/R0514
Principal Display Panel
Compare to Tylenol® Arthritis Pain the active ingredient**
H-E-B®
ARTHRITIS PAIN RELIEF
acetaminophen
Extended-Release Tablets, USP 650 mg
Pain Reliever/Fever Reducer
Lasts up to 8 hrs
• For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
See New Warning
Use only as directed.
50 CAPLETS*
(*Capsule-Shaped Tablets)
50's Bottle Carton Label (Apapgeltabs)
* Please review the disclaimer below.
