DOLO-NEUROBION- acetaminophen tablet, film coated

Dolo-NeuroBion by

Drug Labeling and Warnings

Dolo-NeuroBion by is a Otc medication manufactured, distributed, or labeled by BENARD INDUSTRIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
 headache  muscular aches   minor pain of arthritis   backache   the common cold   toothache  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 in 24 hours, which is the maximum daily amount
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.

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 use 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 at room temperature 59°-86°F (15°-30°C)
 TAMPER EVIDENT child resistant packets
 do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

305.594.0480

SPL UNCLASSIFIED SECTION

EXTRA STRENGTH

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

See Warnings Information & Directions

See acetaminophen warnings
Do not use if pouch is opened

Child-Resistant Packets

Retain carton for complete product information

Distributed by:
OTC Pharmaceutical Products
Doral, FL 33172 
www.otcpharmausa.com © 2023

Packaging

INGREDIENTS AND APPEARANCE

DOLO-NEUROBION 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55959-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55959-131-01	50 in 1 BOX	11/30/2023
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/30/2023

Labeler - BENARD INDUSTRIES INC (106700321)