Drug Facts
OTC - ACTIVE INGREDIENT SECTION
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
OTC - PURPOSE SECTION
Uses
- for the temporary relief of minor aches and pains associated with
- headachebackachemuscular achespremenstrual and menstrual crampsthe common cold and flutoothachefor minor pains from arthritistemporarily reduces fever
WARNINGS SECTION
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
Ask a doctor before use if you are
- 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
OTC - DO NOT USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
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 childrenunder 12 years of age. This product will provide more than therecommended dose (overdose) of non-aspirin and could cause serious health problems |
INDICATIONS & USAGE SECTION
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 INGREDIENT SECTION
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.
OTC - QUESTIONS SECTION
Questions or Comments? 1-866-595-5598
Llorens International Division, Miami, Fl 33166