Drug Facts
Composition & Profile
Identifiers & Packaging
Product Label AP SAFE ® NDC 76821-526-24 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL ® ORAL SUSPENSION* Children's Pain & Fever Acetaminophen Oral Suspension Pain reliever/Fever Reducer • Alcohol-Free • Ibuprofen Free • Aspirin Free • For Ages 2 to 11 4 FL OZ (118 mL) 160 mg per 5 mL Grape Flavor DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol ® Oral Suspension. Manufactured by: AptaPharma Inc. 1533 Union Ave. Pennsauken. NJ 08110 AP-BX-06 Carton Bottle Carton Bottle res 526-24 4OZ Box 526-24 4OZ Btl 526-23 03 2 Oz Box 526-23 03 2 Oz Botl
- Product Label AP SAFE ® NDC 76821-526-24 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL ® ORAL SUSPENSION* Children's Pain & Fever Acetaminophen Oral Suspension Pain reliever/Fever Reducer • Alcohol-Free • Ibuprofen Free • Aspirin Free • For Ages 2 to 11 4 FL OZ (118 mL) 160 mg per 5 mL Grape Flavor DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol ® Oral Suspension. Manufactured by: AptaPharma Inc. 1533 Union Ave. Pennsauken. NJ 08110 AP-BX-06 Carton Bottle Carton Bottle res 526-24 4OZ Box 526-24 4OZ Btl 526-23 03 2 Oz Box 526-23 03 2 Oz Botl
Overview
Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
Indications & Usage
Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
Dosage & Administration
Directions (Children's Pain & Fever) ■ this product does not contain directions or complete warnings for adult use. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. 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 1/2 tsp0 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 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. Directions (Infants' Pain Relief) ■ this product does not contain directions or complete warnings for adult use. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. Weight (lb) Age (Yr) Dose (mL)* Under 24 Under 2 years Ask a doctor 24-35 2-3 years 5 mL *or as directed by a doctor Attention: use only enclosed dosing syringe specifially designed for use with this product. Do not use any other dosing device.
Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur nyour 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 ever, headache, rash. nausea or vomiting, consult a doctor promptly.
Purpose
Purpose Pain reliever/fever reducer
Do Not Use
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 is allergic to acetaminophen or any other of the inactive ingredients in this product.
When Using
When using this product do not exceed recommended dose (see overdose warning)
Stop Use & Ask a Doctor
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 ■ redness or swelling is present. These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children.
Questions
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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