CHILDRENS CHEWABLE ACETAMINOPHEN
[Gemini Pharmaceuticals, Inc. dba Plus Pharma ]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Temporarily relieves minor aches and pain due to:
■ The common cold ■ Flu ■ Headache ■ Sore throat
Temporarily reduces fever.
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 other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
■ If your child is allergic to acetaminophen or any of the inactive ingredients in this products.
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.
■ This products does not contain directions or complete warning for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.
|Under 24 lbs||Under 2 years||Ask a doctor
|24-35 lbs||2-3 years||2 tablets
|36-47 lbs||4-5 years||3 tablets
|48-59 lbs||6-8 years||4 tablets
|60-71 lbs||9-10 years||5 tablets
|72-95 lbs||11 years||6 tablets
- Phenylketonurics: Contain phenylalanine 14 mg per tablet
- Store at room temperature in a dry place
Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.
If you have any questions or comments, or to report an adverse drug event, please contact (800) 795-9775.
See New Warning Information
PAIN RELIEVER/FEVER REDUCER
CONTAINS NO ASPIRIN
*Compare the active ingredients to Children Chewable Tylenol®
30 Chewable Tablet ■ 80 mg Each
Do not use if imprinted seal under cap is broken or missing.
|CHILDRENS CHEWABLE ACETAMINOPHEN
acetaminophen tablet, chewable
|Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)|
|Gemini Pharmaceuticals, Inc. dba Plus Pharma||055942270||manufacture|