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- NDC Code(s): 56062-484-71, 56062-484-78, 56062-484-83, 56062-484-85
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 24, 2020
If you are a consumer or patient please visit this version.
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- Active ingredient (in each caplet)
Acetaminophen 500 mg
- Purpose
Pain reliever/fever reducer
See AlsoWhat is the L484 White Pill? Uses, Side Effects, and Important Information - Live Free Recovery Services | New Hampshire Addiction TreatmentLortab 10 (Hydrocodone Bitartrate and Acetaminophen Tablets): Side Effects, Uses, Dosage, Interactions, WarningsAcetaminophen Extra Strength oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMDL484 Pill: What You Need to Know - California Prime Recovery - Uses
- •
- temporarily relieves minor aches and pains due to:
- •
- the common cold
- •
- headache
- •
- backache
- •
- minor pain of arthritis
- •
- toothache
- •
- muscular aches
- •
- premenstrual and menstrual cramps
- •
- temporarily reduces fever
- Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- 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 have ever had an allergic reaction to this product or any of its ingredients
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.
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 6 hours while symptoms last
- •
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- •
- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- •
- store at 20-25ºC (68-77ºF)
- Inactive ingredients
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain one or more of these ingredients
- Principal Display Panel
EXTRA STRENGTH
pain relief
ACETAMINOPHEN 500 mg
Pain reliever/fever reducer
For adults
ACTUAL SIZE
250 CAPLETS
Compare to Extra Strength Tylenol® Caplets active ingredient
- INGREDIENTS AND APPEARANCE
PAIN RELIEFEXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-484 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-484-78 1 in 1 CARTON 09/15/1988 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:56062-484-71 1 in 1 CARTON 09/15/1988 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:56062-484-83 1 in 1 CARTON 03/09/2018 3 225 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:56062-484-85 1 in 1 CARTON 03/20/2000 4 250 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/15/1988 Labeler -Publix Super Markets Inc(006922009)
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Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
Number of versions: 7
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Oct 6, 2020 | 7 (current) | download |
| Nov 13, 2018 | 6 | download |
| Mar 28, 2018 | 5 | download |
| Dec 19, 2017 | 4 | download |
| Jun 19, 2014 | 3 | download |
| Mar 29, 2013 | 2 | download |
| Sep 22, 2011 | 1 | download |
RxNorm
PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 198440 | acetaminophen 500 MG Oral Tablet | PSN |
| 2 | 198440 | acetaminophen 500 MG Oral Tablet | SCD |
| 3 | 198440 | APAP 500 MG Oral Tablet | SY |
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PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
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NDC Codes
PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 56062-484-71 |
| 2 | 56062-484-78 |
| 3 | 56062-484-83 |
| 4 | 56062-484-85 |
