DOLO- NEUROBION ACETAMINOPHEN 500MG- 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 (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

www.otcpharmausa.com

SEE ACETAMINOPHEN WARNINGS

Packaging

INGREDIENTS AND APPEARANCE

DOLO- NEUROBION  ACETAMINOPHEN 500MG
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55959-171
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
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
Color	yellow	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	DOLO;N
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55959-171-03	1 in 1 CARTON	05/04/2016
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 55959-171-06	1 in 1 CARTON	05/04/2016
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/04/2016

Labeler - BENARD INDUSTRIES INC (106700321)