DOLO- NEUROBION ACETAMINOPHEN 500MG- acetaminophen tablet, film coated 
BENARD INDUSTRIES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dolo-NeuroBion

Drug Facts

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

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

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

www.otcpharmausa.com

SEE ACETAMINOPHEN WARNINGS

Packaging

NeuroB-1

NeuroB-2

DOLO- NEUROBION  ACETAMINOPHEN 500MG
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55959-171
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize13mm
FlavorImprint Code DOLO;N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55959-171-031 in 1 CARTON05/04/2016
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:55959-171-061 in 1 CARTON05/04/2016
260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/04/2016
Labeler - BENARD INDUSTRIES INC (106700321)

Revised: 9/2023
Document Id: 25fc0425-0cc9-4119-9226-12366eeadc16
Set id: 16f8415d-8190-4212-b487-c0caf7d3bee2
Version: 1
Effective Time: 20230907
 
BENARD INDUSTRIES INC