Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Regular Strength Pain Relief
- Manufacturer
- Belmora LLC | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
- Effective date
- 2026-09-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-09-25 02:01:36
Label at a glance#
ProductRegular Strength Pain Relief
Active ingredientACETAMINOPHEN
Label structure11 sections
Dosage and administration
do not take more than directed ( see Overdose warning) adults and children 12 years and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 ...
Storage and handling
store at 15°-30°C (59°-86°F) and avoid excessive heat.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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 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 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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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.
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 and children 12 years and over |
|
children 6 years to under 12 years |
|
children under 6 years | ask a doctor |
Other information
- store at 15°-30°C (59°-86°F) and avoid excessive heat.
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white ink
Questions or comments?
Call toll free: 1-888-779-2877
Monday to Friday 9AM - 5PM EST
PRINCIPAL DISPLAY PANEL - Carton Label
NDC 27854-388-01
Regular Strength
PARACETAMOL
Pain Reliever/Fever Reducer
Acetaminophen 325 mg
RAPID RELEASE
Contains no aspirin
20 SOFTGELS
*Compare to the active ingredient in TYLENOL® Regular Strength
PRINCIPAL DISPLAY PANEL - Bottle Label
NDC 27854-388-01
Regular Strength
PARACETAMOL
Pain Reliever/Fever Reducer
Acetaminophen 325 mg
Contains no aspirin
20 SOFTGELS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0853030002816 | GTIN-13: 0853030002816 EAN-13: 0853030002816 GTIN-12: 853030002816 UPC-A: 853030002816 GTIN storage (14 digits): 00853030002816 | carton-back-02.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Regular Strength Pain Relief
- ACETAMINOPHEN
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 27854-388 | 27854-388-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-11-21 | full-release | 2026-06-01 00:38:40 |
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 |
|---|---|---|---|---|---|---|
| 2778e49c-0d1c-e458-e063-6394a90a0f19 | 2c69ba78-dee4-4bac-b247-21eb561ee38b | 2024-11-21 | Warnings | 2c69ba78-dee4-4bac-b247-21eb561ee38b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.