Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Acetaminophen (NDC 17856-0166). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, liver warning, sore throat warning:, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain Reliever/Fever Reducer
trmporarily:
This product contains acetaminophen.
Severe liver damage may occur if your child takes:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor before use if your child has
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product: Do not exceed recommended dose
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.
| Weight (lbs.) | Age (years) | dosage-teaspoonful (tsp.) |
| under 24 | under 2 | ask a doctor |
| 24 to 35 | 2 to 3 | 1 tsp or 5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL |
| 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 72 to 95 | 11 | 3 tsp or 15 mL |
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
bubble gum flavor, citric acid, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.
Questions or Comments?
Call (877) 225-6999 Monday - Friday 9AM-5PM EST
DISTRIBUITED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir
* Please review the disclaimer below.