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
ValuRx Extra Strength Pain Reliever mini softgels
- Manufacturer
- Shield Pharmaceuticals Corp
- Effective date
- 2026-08-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-08-07 01:01:23
Label at a glance#
ProductExtra Strength Pain Reliever mini softgels
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not use more than directed (see overdose warning ) adults and children 12 years and over: take 2 softgels every 6 hours while symptoms last do not take more than 6 softgels 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each softgel)
Acetaminophen 500 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 nonprescription). 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 you have
- liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- 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 use more than directed(see overdose warning)
| adults and children 12 years and over: |
|
| children under 12 years: |
|
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive ingredients
FD&C Red No. 40, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide
Questions or comments?
1-800-373-6981
SPL UNCLASSIFIED SECTION
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Principal Display
Extra Strength
Pain Reliever
mini softgels
Acetaminophen 500 mg
Pain reliever / Fever reducer
Carton
Label
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0383059000215 | GTIN-13: 0383059000215 EAN-13: 0383059000215 GTIN-12: 383059000215 UPC-A: 383059000215 GTIN storage (14 digits): 00383059000215 | Pain Relief softgel Carton.jpg |
Products#
Every source-derived product name is available through these pages.
- Extra Strength Pain Reliever mini softgels
- Acetaminophen 500 mg
- ACETAMINOPHEN
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- ISOPROPYL ALCOHOL
- N-BUTYL ALCOHOL
- POLYETHYLENE GLYCOL 400
- POLYSORBATE 80
- PROPYLENE GLYCOL
- WATER
- SHELLAC
- SORBITOL SOLUTION
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83059-0168 | 83059-0168-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| N-BUTYL ALCOHOL | 8PJ61P6TS3 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | 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 |
|---|---|---|---|---|---|---|
| Extra Strength Pain Reliever mini softgels | ACETAMINOPHEN 500 MG | Shield Pharmaceuticals Corp | 0ebb1902-6f8a-4bfb-9f2e-839d43bfca37 | 2026-08-04 | Warnings | 83059-0168-1 83059-0168 83059016801 583e4167-fdd9-c249-e063-6294a90aba21 0ebb1902-6f8a-4bfb-9f2e-839d43bfca37 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.