Indications and 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
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
do not take more than directed (see Overdose warning) adults & children 12 years and over: take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets 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
Store at 20 - 25ºC (68 - 77ºF)
Drug Facts
Acetaminophen, 500 mg
Aspirin and Caffeine Free
Pain reliever/fever reducer
Compare to Active Ingredient in Tylenol® Extra Strength Tablets.
This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark ExtraStrength TYLENOL®.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Taking more than the recommended dose (overdose) may cause liver damage. 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.
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:
Ask your doctor or pharmacist before use:
Stop use: Stop use and ask a doctor if
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
do not take more than directed (see Overdose warning)
adults & children 12 years and over:
children under 12 years: ask a doctor
Store at 20 - 25ºC (68 - 77ºF)
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Each tablet contains 0.22 mg of Sodium.
1-212-594-3260, 9:00 am – 5:00 pm EST, Monday-Friday
Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing.
LB-5427-06EN 200305V1.1
Tested by Ameripharma Labs, LLC, Somerset, NJ, 08873
Packaged by Unipharm, Inc., Waterbury, CT, 06705
Distributed by Unipharm, Inc., New York, NY, 10118
Made in the USA
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62900-542-60 | 2024-02-22 | C162847 | 48780-1 | d6a99b39-d5c4-a426-e053-dadaa90af4c2 | RELORN ACETAMINOPHEN TABLETS, USP 500 mg |
| 62900-542-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d5c4-a426-e053-dadaa90af4c2 | RELORN ACETAMINOPHEN TABLETS, USP 500 mg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62900-542 | 62900-542-60 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 10b9cfe0-7e1a-780e-e063-6394a90ab4ef | d59f71a2-994a-4e55-a3d5-f71815372a4a | 2024-02-06 | Warnings | d59f71a2-994a-4e55-a3d5-f71815372a4a |
Adverse event summaries are temporarily unavailable. Other product information remains available.