Dolo-neurobion

Dolo-neurobion
SPL v2
SPL
SPL Set ID 16f8415d-8190-4212-b487-c0caf7d3bee2
Route
ORAL
Published
Effective Date 2023-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-04

Description

Acetaminophen 500mg

Purpose

Pain reliever/ Fever reducer


Medication Information

Purpose

Pain reliever/ Fever reducer

Description

Acetaminophen 500mg

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

Section 42229-5

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

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.

Packaging

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

Drug Facts

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

Active Ingredient (per Tablet)

Acetaminophen 500mg

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.


Structured Label Content

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

Section 42229-5 (42229-5)

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

Purpose

Pain reliever/ Fever reducer

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.

Packaging

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

Drug Facts

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • Do not use if seal under cap is broken or missing
Inactive Ingredients: (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? (Questions or comments?)

Call 1-800-595-0480

Active Ingredient (per Tablet) (Active Ingredient (per tablet))

Acetaminophen 500mg

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)