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Drug Facts
Acetaminophen Liquid
FDA Label NDC 71205-730
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Acetaminophen (NDC 71205-730). 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 other, active ingredient (in each 5 ml teaspoonful), purpose, uses, liver warning, allergy alert, ask a doctor before use, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Teaspoonful)
Acetaminophen, USP 160 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to:
▪ headache▪ muscular aches▪ backache▪ arthritis▪ the common cold▪ toothache▪ menstrual cramps▪ reduces fever
Liver Warning
This product contains acetaminophen.
Severe liver damage may occur if you take:
▪ more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount▪ 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.
Ask A Doctor Before Use
if you have health issues especially liver disease.
Ask A Doctor Or Pharmacist Before Use
if you are taking other drugs, including the blood thinner warfarin.
Otc - Do Not Use
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
▪ for more than 10 days for pain unless directed by a doctor▪ for more than 3 days for fever unless directed by a doctor▪ if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Stop Use And Ask A Doctor If
▪ new symptoms occur such as rash, hives, itching or hoarseness▪ redness or swelling is present▪ pain gets worse or lasts for more than 10 days▪ fever gets worse or lasts for more than 3 days▪ symptoms do not improve
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 even if you do not notice any signs or symptoms.
Directions
Do not exceed recommended dosage.
Overdose Warnings
Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.
▪ adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours▪ children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.
Other Information
If dispensed, dispense in a tight, light resistant container with a child-resistant cap.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
Inactive Ingredients
Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate,Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.
Questions?
You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-7294 or FDA at 1-800-FDA-1088.
Principal Display Panel – 4 Fl. Oz. (118 Ml) Bottle Label
NDC 71205-730-04
Acetaminophen
Liquid
160 mg/5 mL
Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free
CHERRY FLAVOR
4 fl. oz. (118 mL)
71205-730-04 (Acetaminophen 01)
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