Dologesic description, usages, side effects, indications, overdosage, supplying and lots more!

Dologesic

Llorens Pharmaceutical International Division

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts



FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients in each tablespoonful (15 mL)           Purpose

Acetaminophen, USP .................... 500 mg/15mL......................Pain Reliever/Fever Reducer

Phenyltoloxamine Citrate, USP ........ 30 mg/15mL......................Pain Reliever

Alcohol, USP....................................... 5%...............................Pharmaceutical Aid


Purpose

Uses

  • for the temporary relief of minor aches and pains associated with
    • headache
    • backache
    • muscular aches
    • premenstrual and menstrual cramps
    • the common cold and flu
    • toothache
    • for minor pains from arthritis
    • temporarily reduces fever

Alcohol Warning:If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

Acetaminophen may cause liver damage.


When using this product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol and sedatives may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Ask a doctor before use if you are

  • taking tranquilizers or sedatives
Ask a doctor before use if you have
  • glaucoma
  • emphysema
  • asthma
  • chronic pulmonary disease
  • trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
  • pain persists for more than 10 days, or redness is present, or in conditions affecting children 12 years of age, consult a physician immediately
  • if relief does not occur within 3 days, discontinue use and consult a physician

Do not give to children under 3 years of age or more use for more than 10 days unless directed by a physician

Do not take this product for more than 10 days and do not take for fever for more than 3 days unless directed by a physician


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If pregnant or breast-feeding, ask a health professional before use.

Directions Do not exceed 8 tablespoons in any 24-hour period or as directed by a doctor

adults and children 12 years of age and older
take 1 or 2 tablespoons every 4 to 6 hours
children under 12 years of age
Consult a physician; do not give this product to children
under 12 years of age. This product will provide more than the
recommended dose (overdose) of non-aspirin and could cause
serious health problems

Uses

Other information store at controlled room temperature 20 - 25 degrees C (68 - 77 degrees F); excursions permitted to 15 - 30 degrees C (59 - 86 degrees F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.


Inactive ingredients:Citric Acid, Ethanol (5 percent by volume), FD and C Yellow Number 6, Glycerin, Menthol, Methylparaben, Peach Flavor, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water and Sugar.

Questions or Comments? 1-866-595-5598

Llorens International Division, Miami, Fl 33166

Dologesic

Acetaminophen, Phenyltoloxamine Citrate, Alcohol LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54859-512
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
Phenyltoloxamine Citrate PHENYLTOLOXAMINE 30 mg
ALCOHOL ALCOHOL 0.75 mL

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
ALCOHOL
GLYCERIN
FD&C YELLOW NO. 6
MENTHOL
METHYLPARABEN
POTASSIUM SORBATE
propylene glycol
water
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54859-512-06 177 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1994-09-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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