Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, PHENYLTOLOXAMINE CITRATE 30mg in 15mL, ALCOHOL 0.75mL in 15mL
Labeler: Llorens Pharmaceutical International Division
NDC Code: 54859-512
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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
- for the temporary relief of minor aches and pains associated with
- muscular aches
- premenstrual and menstrual cramps
- the common cold and flu
- 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
- chronic pulmonary disease
- trouble urinating due to an enlarged prostate gland
- 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
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
acetaminophen, phenyltoloxamine citrate, alcohol liquid
|Labeler - Llorens Pharmaceutical International Division (037342305)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.