FDA Label for Liquid Acetaminophen
View Indications, Usage & Precautions
Liquid Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient (In Each 5 Ml Tsp)
Acetaminophen, 160 mg
Purpose
Pain reliever/Fever reducer
Uses:
Temporarily relieves of minor aches and pains due to • headache • backache • muscular aches • minor pain of arthritis • the common cold • toothache • premenestrual and menstrual cramps
Temporarily reduces fever.
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
• adults take more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen (prescription or nonprescription)
• adults has 3 or more alcoholic drinks 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 product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE
Ask a doctor before use if you have a liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if • pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days • new symptoms occur
• redness or swelling is present. These could be signs of a serious condition.
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 (1-800-222-1222) right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
Directions
Dosage may be repeated every 4 hours, or as directed by doctor.
Do not exceed recommended dose.
Find dose in chart below. If possible, use weight to dose, otherwise use age.
| Weight (lbs) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 | Over 95 |
| Age (years) | Under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | 12 to adult |
| Dosage teaspoonful (tsp) | consult a doctor | 1 tsp (5 mL) | 1 1/2 tsp (7.5 mL) | 2 tsp (10 mL) | 2 1/2 tsp (12.5 mL) | 3 tsp (15 mL) | 4 tsp (20 mL) |
Other Information
• Store at controlled room tempearature 15°-30°C (59°-86°F). Do not refrigerate.
• Protect from light. Avoid excessive heat or humidity.
Inactive Ingredients
Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose
Questions Or Comments?
Call weekdays from 8 AM to 4 PM AST at 787-767-2072.
Manufactured in the USA for Kramer Novis, San Juan, PR 00917
Packaging
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