FDA Label for Llorens Care Children Acetaminophen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5ML = 1 TEASPOON)
- PURPOSE
- INDICATIONS & USAGE
- LIVER WARNING
- SORE THROAT WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS? COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Llorens Care Children Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division, Inc.. 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.
Active Ingredient (In Each 5Ml = 1 Teaspoon)
Acetaminophen 160 mg
Purpose
Pain Reliever / Fever Reducer
Indications & Usage
Uses
- temporarily reduces fever
- temporarilty relieves minor aches and pains due to:
- headache
- sore throat
- the common cold
- toothache
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen.
- skin reddening
- blisters
- rash
Allergy Alert:
acetaminophen may cause sever skin reactions. Symptoms may include
If a skin reaction occurs, stop use and seek medical help right away.
Sore Throat Warning
if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Otc - Ask Doctor
When using this product: Do not exceed recommended dose.
Ask a doctor before use if your child hasliver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 5 days
- 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- do not give more than directed
- shake well before using
- this product does not contain directions or complete warnings for adult use
- find dose in chart below; if possible, use weight to dose, otherwise use age
- dosage may be repeated every 4 hours, or as directed by a doctor
- do not give more than 5 times in 24 hours
| 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 physician | 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) |
Inactive Ingredients
artifical and natural grap flavor, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium, potassium sorbate, purified water, sorbitol solution, sucralose, and xanthan gum
Questions? Comments?
Call 1-866-595-5598
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