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
Regular Strength Pain Reliever
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:35
Label at a glance#
ProductRegular Strength Pain Reliever
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not take more than directed (see overdose warning) adults & children 12 years & over • take 2 tablets every 4 to 6 hours while symptoms last • do not take more than 10 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years • take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hour...
Storage and handling
• store between 20–25°C (68–77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
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.
OTC - DO NOT USE SECTION
Do not use • with any other drug containing acetaminophen (prescription or non prescription). 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 SECTION
Ask a doctor before use if the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
OTC - STOP USE SECTION
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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 & children 12 years & over | • take 2 tablets every 4 to 6 hours while symptoms last
• do not take more than 10 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor |
| children 6 years to under 12 years | • take 1 tablet every 4 to 6 hours while symptoms last
• do not take more than 5 tablets in 24 hours • do not use for more than 5 days unless directed by a doctor |
| children under 6 years | ask a doctor |
Other information
• store between 20–25°C (68–77°F)
Inactive ingredients
croscarmellose sodium, povidone, pregelatinized starch, stearic acid
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
Principal Display Panel
Label
Carton
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-5019-6 | Regular Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 | |
| 68210-5019-6 | Regular Strength Pain Reliever | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-5019 | REGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 4 | 2 package rows | 20241213_d4457496-98c1-4bd5-a91f-e4e9e77c8061.zip |
Products#
Every source-derived product name is available through these pages.
- Regular Strength Pain Reliever
- Acetaminophen
- CROSCARMELLOSE SODIUM
- POVIDONE
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-5019 | 68210-5019-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 2905401c-42bc-8fcc-e063-6294a90acdc6 | d4457496-98c1-4bd5-a91f-e4e9e77c8061 | 2024-12-11 | Warnings | 2905401c-42bc-8fcc-e063-6294a90acdc6 d4457496-98c1-4bd5-a91f-e4e9e77c8061 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.