OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Pain Free Plus
- Manufacturer
- Afassco Inc. | ULTRAtab Laboratories, Inc. | Ultra Seal Corporation
- Effective date
- 2019-09-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:00:33
Label at a glance#
ProductPain Free Plus
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Pin reliever, Stimulant
INDICATIONS & USAGE SECTION
Uses: For the temporary relief of pain from:
• headaches • muscular aches
• menstrual cramps • toothaches
• minor arthritic pain • colds
WARNINGS SECTION
WARNING:
Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or non-prescription)
• 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.
Children under 12 years of age: Consult a doctor.
INACTIVE INGREDIENT SECTION
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
res
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51532-0560-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3dae-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51532-0560-2 | Pain Free Plus | 2 in 1 PACKET | TABLET | 2 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51532-0560 | PAIN FREE PLUS (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [AFASSCO INC.] | 5 | Legacy NDC, 1 package rows | 20190923_9968232c-6039-4f4a-a51d-093c543192db.zip |
Products#
Every source-derived product name is available through these pages.
- Pain Free Plus
- Acetaminophen, Aspirin, Caffeine
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- STARCH, CORN
- HYPROMELLOSES
- MALTODEXTRIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51532-0560 | 51532-0560-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| 7f2110ff-0645-4106-8d8d-058bee3097aa | 9968232c-6039-4f4a-a51d-093c543192db | 2019-09-21 | Warnings | 7f2110ff-0645-4106-8d8d-058bee3097aa 9968232c-6039-4f4a-a51d-093c543192db |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.