Indications and uses
(Uses) Update "Temporarily relieves symptoms of pain, including:" to "Temporarily relieves:" Removed extra bullets
Pain Relief
- Manufacturer
- Hyland's Inc.
- Effective date
- 2023-05-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:08
Label at a glance#
ProductPain Relief
Active ingredientMAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, DIBASIC POTASSIUM PHOSPHATE, BRYONIA ALBA ROOT, HYPERICUM PERFORATUM
Label structure10 sections
Dosage and administration
■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.
Contacts and useful links#
Websitewww.hylands.com
www.hylands.com
www.hylands.comLabel contents#
Full prescribing information#
OTC - PURPOSE SECTION
Pain Relief
Drug Facts
Active ingredients
Active ingredients | Purpose |
Bryonia Alba 6X HPUS | minor joint pain, headache, muscle cramps |
Hypericum Perforatum 6X HPUS | backache, headache, minor joint pain |
Kali Phosphoricum 6X HPUS | pain in neck/shoulders, headache |
Magnesia Phosphorica 12X HPUS | muscle pain, backache |
Rhus Toxicodendron 6X HPUS | minor joint pain, headache, neck pain |
"HPUS" indicates that the active ingredients are in the official Homeopathic
Pharmacopoeia of the United States.
Warnings
Stop use and ask a doctor if
■ pain gets worse or lasts more than 7 days.
■ new symptoms occur.
■ redness or swelling is present.
If pregnant or breastfeeding
Ask a health professional before use.
Keep out of reach of children.
Directions
■ Use as directed.
| Adults and children
12 years and over | At onset of symptoms, dissolve 2 tablets under tongue every
15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. |
| Children under
12 years of age | Ask a doctor before use. |
Inactive ingredients
Acacia Gum, Lactose.
Questions?
www.hylands.com or care@hylands.com
Indications and Usage
(Uses)
Update "Temporarily relieves symptoms of pain, including:" to "Temporarily relieves:"
Removed extra bullets
Dosage and Administration
(Directions)
■ Use as directed
| Adults and children
12 years and over | At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every
|
| Children under
12 years of age | Ask a doctor before use. |
Uses
■ Temporarily relieves: ■ minor joint pain ■ headache ■ muscle pain ■ backache ■ muscle cramps ■ pain in neck or shoulders
Principal Display Panel
54973-4009-01
100 Tablets
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54973-4009-1 | Pain Relief | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 54973-4009-1 | Pain Relief | 1 in 1 CARTON | TABLET | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-4009 | PAIN RELIEF (DIBASIC POTASSIUM PHOSPHATE,HYPERICUM PERFORATUM,TOXICODENDRON PUBESCENS LEAF,BRYONIA ALBA ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE) TABLET [HYLAND'S INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230510_a57ac701-c42d-6b2f-e053-2995a90a112d.zip |
Products#
Every source-derived product name is available through these pages.
- Pain Relief
- DIBASIC POTASSIUM PHOSPHATE,HYPERICUM PERFORATUM,TOXICODENDRON PUBESCENS LEAF,BRYONIA ALBA ROOT and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- LACTOSE MONOHYDRATE
- ACACIA
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- TOXICODENDRON PUBESCENS LEAF
- DIBASIC POTASSIUM PHOSPHATE
- POTASSIUM CATION
- BRYONIA ALBA ROOT
- HYPERICUM PERFORATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-4009 | 54973-4009-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| ACACIA | 5C5403N26O | IACT |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | HF539G9L3Q | ACTIB |
| TOXICODENDRON PUBESCENS LEAF | 6IO182RP7A | ACTIB |
| DIBASIC POTASSIUM PHOSPHATE | CI71S98N1Z | ACTIB |
| BRYONIA ALBA ROOT | T7J046YI2B | ACTIB |
| HYPERICUM PERFORATUM | XK4IUX8MNB | 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 |
|---|---|---|---|---|---|---|
| Pain Relief | DIBASIC POTASSIUM PHOSPHATE,HYPERICUM PERFORATUM,TOXICODENDRON PUBESCENS LEAF,BRYONIA ALBA ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | Hyland's Inc. | a57ac701-c42d-6b2f-e053-2995a90a112d | 2023-05-08 | Warnings | 54973-4009-1 54973-4009 54973400901 fb360897-c464-de3b-e053-6294a90a6e36 a57ac701-c42d-6b2f-e053-2995a90a112d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.