The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division for the product Dologesic (NDC 54859-512). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Uses
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
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
Dologesicliquid (Dologesic)
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