Acetaminophen Tablets For Children
Drug Labeling and Warnings
Drug Details [pdf]
ACETAMINOPHEN- acetaminophen tablet
Rugby Laboratories Inc.
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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Acetaminophen Tablets
For Children
Uses
For the temporary relief of minor aches and pains due to:
- common cold
- flu
- headache
- sore throat
- toothache
WARNINGS
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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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
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 appear
- redness or swelling is present
These could be signs of a serious condition.
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, even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- find correct dose below
- if possible use weight to dose, otherwise use age
- chew tablets before swallowing
- give dose every 4 hours while symptoms last
- do not give more than 5 doses in 24 hours
| Weight | Age | Dose |
|---|---|---|
|
72 - 95 lbs |
11-12 years |
4 – 6 tablets |
|
60 - 71 lbs |
9 - 10 years |
4 – 5 tablets |
|
48 - 59 lbs |
6 - 8 years |
4 tablets |
|
36 - 47 lbs |
4 - 5 years |
3 tablets |
|
24 - 35 lbs |
2 - 3 years |
2 tablets |
|
under 24 lbs |
under 2 years |
ask a doctor |
Inactive Ingredients
citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose syrup
Questions or Comments
Call 1-800-645-2158
Children's Pain & Fever is manufactured for Rugby Laboratories, Inc.
Duluth, Georgia 30097
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
18 mL Bottle Carton
ASPIRIN FREE
NDC: 0536-3233-07
Rugby
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| ACETAMINOPHEN
acetaminophen tablet |
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| Labeler - Rugby Laboratories Inc. (079246066) |