DOLONEURO-TROPAS- acetaminophen, caffeine tablet, film coated

DOLONEURO-TROPAS by

Drug Labeling and Warnings

DOLONEURO-TROPAS by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, HBC HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

• Acetaminophen 500mg
• Caffeine 65 mg

Purpose

• Pain reliever
• Pain reliever aid

Uses

• temporarily relief minor aches and pains due to:
• headache
• muscular aches

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 tablets 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing metications, foods, or beverages while taking this product because too much cafeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

• with anyother drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask a doctor before use

if you have liver disease

Ask a doctor or pharmacist if

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• any new symptoms appear
• symptoms do not get better or worsen
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 exceed recommended dosage.
• adults and children 12 years and over: take 2 tablets every 6 hours;
  do not take more than 6 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at controlled room temperatur 20° -25°C (68° -77°F)
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystaline cellulose, polyethylene glycol, pregelatinized starch, polyvinyl pyrolidone, stearic acid, tale, titanium dioxide

Questions or coments?

Call for free 619-600-5632 Monday through Friday 9AM -5PM EST

PLEASE REFER TO LEAFLET FOR INSTRUCTION IN SPANISH.

CONSULTE EL FOLLETO PARA LAS INTRUCCIONES EN ESPAÑOL.

SPL UNCLASSIFIED SECTION

Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632

Made for:
inov
FARMACEUTIQUE

PRINCIPAL DISPLAY PANEL

NDC: 69729-795-80

DOLONEURO-TROPAS

NUEVAFORMULA

NEW FORMULA

Treat Pain or Inframation caused by conditions such as:
Alivio temporal de dolores leves y malestares debidos a:

• Reumatismo
• Artritis
• Inflamacion
• Dolor
• Rheumatism
• Arthritis
• Inflamation
• Pain

20 Sachets of 4 Caplets

Analgesico/Pain Reliever

INGREDIENTS AND APPEARANCE

DOLONEURO-TROPAS 
acetaminophen, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-795
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K90 (UNII: RDH86HJV5Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	red	Score	no score
Shape	OVAL (Oblong)	Size	17mm
Flavor		Imprint Code	5431
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-795-80	20 in 1 CARTON	01/29/2026
1		4 in 1 BLISTER PACK; 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	01/29/2026

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
HBC HEALTHCARE PRIVATE LIMITED		854255181	manufacture(69729-795)