CHILDREN ACETAMINOPHEN- acetaminophen tablet, chewable
A&Z Pharmaceutical, 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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Children Acetaminophen, 80mg, Fruit Flavored Chewable Tablets
USES
Temporary relief of minor aches and pains associated with ■ common cold and flu ■ headache ■ toothache ■ sore throat ■ immunizations ■ and reduction of fever
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if ■ your child takes more than 5 doses in 24 hours ■ taken 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
When using this product do not exceed recommended dose;
taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems
Stop Use and ask a doctor if
■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050
Keep Out of Reach of Children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt 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 ■ chew tablets before swallowing ■ all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period ■ follow the chart below for proper dosing or as directed by a doctor ■ if possible, use weight for dosing, otherwise use age.
| Weight (lbs) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 |
| Age (yrs) | Under 2 | 2-3 | 4-5 | 6-8 | 9-10 | 11 |
| Tablets | Consult a doctor | 2 | 3 | 4 | 5 | 6 |
| CHILDREN ACETAMINOPHEN
children acetaminophen tablet, chewable |
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| Labeler - A&Z Pharmaceutical, Inc. (926820705) |
| Registrant - A&Z Pharmaceutical, Inc. (926820705) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| A&Z Pharmaceutical, Inc. | 926820705 | manufacture(62211-023) | |