Indications and uses
• temporarily relieves minor aches and pains due to: • the common cold • toothache • headache • muscular aches • backache • premenstrual and menstrual cramps • minor pain of arthritis • temporarily reduces fever
DOLO- NeuroBion
- Manufacturer
- BENARD INDUSTRIES INC
- Effective date
- 2024-11-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:33:35
Label at a glance#
ProductDOLO- NeuroBion Acetaminophen 500mg
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
• do not take more than directed (see overdose warning) Adults and children 12 years and over • take 2 tablets every 6 hours while symptoms last. • do not take more than 6 tablets 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
Storage and handling
store between 20°-25°C (68°-77°F) Do not use if seal under cap is broken or missing
Contacts and useful links#
Websitewww.otcpharmausa.com
www.otcpharmausa.com
www.otcpharmausa.comLabel contents#
Full prescribing information#
Active Ingredient (per tablet)
Acetaminophen 500mg
Purpose
Pain reliever/ Fever reducer
Uses
• temporarily relieves minor aches and pains due to:
• the common cold • toothache
• headache • muscular aches
• backache • premenstrual and menstrual cramps
• minor pain of arthritis
• temporarily reduces fever
Warnings
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
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reaction.
Symptoms may include: • skin reddening • blister • 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
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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
If pregnant or breast-feeding, ask a health professional before use.
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 | • take 2 tablets every 6 hours while symptoms last. • do not take more than 6 tablets 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 |
Other information
- store between 20°-25°C (68°-77°F)
- Do not use if seal under cap is broken or missing
Inactive ingredients:
croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake*, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, titanium dioxide.
*This product contains FD&C Yellow #5 Lake (Tartrazine) as a color additive.
Questions or comments?
Call 1-800-595-0480
SPL UNCLASSIFIED SECTION
For the temporary relief of head, neck and back pain that may be continuous or intermittent
EXTRA STRENGTH
PAIN RELIEVER
FEVER REDUCER
Distributed by:
OTC Pharmaceutical Products
10860 NW 27th St. Doral, FL 33172 ©2013
SEE ACETAMINOPHEN WARNINGS
Packaging
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55959-171-03 | DOLO- NeuroBionAcetaminophen 500mg | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 2 | |
| 55959-171-03 | DOLO- NeuroBionAcetaminophen 500mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 55959-171-06 | DOLO- NeuroBionAcetaminophen 500mg | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 2 | |
| 55959-171-06 | DOLO- NeuroBionAcetaminophen 500mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DOLO- NeuroBion Acetaminophen 500mg
- Acetaminophen
- CROSCARMELLOSE SODIUM
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- FD&C YELLOW NO. 5
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- MINERAL OIL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- SILICON DIOXIDE
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55959-171 | 55959-171-03, 55959-171-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| DOLO- NeuroBion Acetaminophen 500mg | ACETAMINOPHEN | BENARD INDUSTRIES INC | 16f8415d-8190-4212-b487-c0caf7d3bee2 | 2024-11-04 | Warnings | 55959-171-06 55959-171-03 55959-171 55959017103 55959017106 ecd800ee-edcd-42d8-9e95-f88210b41ee5 16f8415d-8190-4212-b487-c0caf7d3bee2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.