OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT IN EACH TABLET-
Acetaminophen 500 mg
ACTIVE INGREDIENT IN EACH TABLET-
Acetaminophen 500 mg
Analgesic, Antipyretic (fever reducer)
Uses: temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor arthritis pain
Temporarily reduces fever
Warnings:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • you have 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 product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
When using this product do not exceed recommended dose.
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 or fever persists or gets worse or lasts for more than 10 days • fever gets worse or lasts for 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: consult a doctor
Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid
*contains one or more of these ingredients
Extra Strength
PAIN RELIEVER
Acetaminophen
Pain Reliever / Fever Reducer
COMPARE TO THE ACTIVE INGREDIENTS IN
TYLENOL ® EXTRA STRENGTH*
6 TABLETS
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 29485-7626-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-3a80-a910-e053-dadaa90a0b85 | c08f5ac3-b2cf-44e8-9e38-259addf61abd |
| 29485-7626-6 | 2021-10-06 | C162847 | 48780-1 | ba0f9c33-3a80-a910-e053-dadaa90a0b85 | c08f5ac3-b2cf-44e8-9e38-259addf61abd |
| 29485-7626-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3a80-a910-e053-dadaa90a0b85 | c08f5ac3-b2cf-44e8-9e38-259addf61abd |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 29485-7626-6 | EXTRA STRENGTH PAIN RELIEVER | 3 in 1 PACKET | TABLET | 3 | 4 | |
| 29485-7626-6 | EXTRA STRENGTH PAIN RELIEVER | 2 in 1 POUCH | TABLET | 2 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 29485-7626 | EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [MECHANICAL SERVANTS LLC] | 4 | Legacy NDC, 2 package rows | 20211008_c08f5ac3-b2cf-44e8-9e38-259addf61abd.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 29485-7626 | 29485-7626-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| b4505356-edfd-3a43-e053-2995a90aa41c | c08f5ac3-b2cf-44e8-9e38-259addf61abd | 2021-10-06 | Warnings | b4505356-edfd-3a43-e053-2995a90aa41c c08f5ac3-b2cf-44e8-9e38-259addf61abd |
Adverse event summaries are temporarily unavailable. Other product information remains available.