American Sales Company Children’s Pain & Fever Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
CAREONE CHILDRENS PAIN AND FEVER- acetaminophen suspension
American Sales Company
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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American Sales Company Children’s Pain & Fever Drug Facts
Uses
temporarily:
- reduces fever
- relieves 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
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.
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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child has ever had an allergic reaction to this product or any of its ingredients
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.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter; tsp = teaspoonful
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child’s dose into the dosing cup
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
|
Weight (lb) |
Age (yr) |
Dose (mL or tsp)* |
|
under 24 |
under 2 years |
ask a doctor |
|
24-35 |
2-3 years |
5 mL (1 tsp) |
|
36-47 |
4-5 years |
7.5 mL (1 ½ tsp) |
|
48-59 |
6-8 years |
10 mL (2 tsp) |
|
60-71 |
9-10 years |
12.5 mL (2 ½ tsp) |
|
72-95 |
11 years |
15 mL (3 tsp) |
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
- each 5 mL (1 tsp) contains: sodium 3 mg
- store at 20-25˚C (68-77˚F)
- do not use if printed neckband is broken or missing
- see bottom panel for lot number and expiration date
Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate
Package/Label Principal Display Panel
Compare to the Active Ingredient in Children’s Tylenol® Oral Suspension
CHILDREN’S PAIN & FEVER
Pain Reliever/Fever Reducer
Acetaminophen 160 mg per 5 mL
Oral Suspension
GRAPE FLAVOR
FOR AGES 2 to 11 YEARS
Fast, Effective Relief of Children’s Pain and Fever
Alcohol Free
Aspirin Free
Ibuprofen Free
Non-Staining
See New Warnings
DYE-FREE
4 FL OZ (118 mL)
| CAREONE CHILDRENS PAIN AND FEVER
acetaminophen suspension |
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| Labeler - American Sales Company (809183973) |