Active Ingredient
(in each 5 mL)
Acetaminophen 160 mg
Childrens Acetaminophen Oral Suspension
FDA Label NDC 70005-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Childrens Acetaminophen Oral Suspension (NDC 70005-040). 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, purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acetaminophen
160 mg.............................Pain reliever/fever reducer
Uses
temporarily
- reduces fever
- minor aches and pains due to:
• the common cold • flu • headache
• sore throat • toothache
Warnings
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
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
Ask A Doctor Before Use If Your Child Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If Your Child
is taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dose (see overdose warning)
Stop Use And Ask A Doctor If
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Enter section text here
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 for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use.
- shake well before using
- mL = mililiter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-35 2-3 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL
always check with your doctor before administering medicine to your infant/child
Other Information
- each teaspoon (5mL) contains: sodium 3 mg
- store between 15-30˚C (59-86˚F)
- protect from freezing
- protect from light
Inactive Ingredients
butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, D&C red # 33, FD&C blue # 1, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
Principal Display Panel
Childrens Acetaminophen Oral Suspension
• Fever reducer
• Pain reliever
Alcohol Free
Aspirin Free
Ibuprofen Free
Grape Flavor
Compare to active ingredient in Childrens Tylenol Fever reducer Pain reliever
2 FL OZ (60 mL)
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