Active Ingredient (In Each 15Ml Tablespoonful)
Acetaminophen 500 mg
Extra Strength Pain Relief Suspension
FDA Label NDC 68788-8375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Extra Strength Pain Relief (NDC 68788-8375). 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 active ingredient (in each 15ml tablespoonful), purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/Fever reducer
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver Warning: This product contains acetaminophen. The maximum
daily dose of this product is 6 tablespoonfuls in 24 hours.
Severe liver damage may occur if you take
• more than 8 tablespoonfuls (4,000 mg of acetaminophen) 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 reactions.
Symptoms may include: • skin reddening • blisters • 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 non-prescription). 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product: Do not exceed recommended dose.
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
Adults and children 12 years of age and older | Take 1-2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours |
Children under 12 years | Do not use |
Other Information
- store at room temperature 15°- 30°C (59°-86°F)
- protect from freezing
- protect from light
- TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.
Inactive Ingredients
artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Questions Or Comments?
1-800-540-3765
Relabeled By: Preferred Pharmaceuticals Inc.
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