Active Ingredient (In Each 5 Ml = 1 Teaspoon)
Acetaminophen 160 mg
Childrens Acetaminophen
FDA Label NDC 53807-520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Childrens Acetaminophen (NDC 53807-520). 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 = 1 teaspoon), 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.
Label Section Quick Index
Purpose
Pain reliever/Fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- immunizations
- toothache
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 drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
Stop Use And Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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.
- shake well before using
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- only use enclosed measuring cup
| Weight (lbs.) | Age (yrs.) | Dose (tsp or mL) |
|---|---|---|
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 1 tsp or 5 mL |
| 36-47 | 4-5 | 1½ tsp or 7.5 mL |
| 48-59 | 6-8 | 2 tsp or 10 mL |
| 60-71 | 9-10 | 2½ tsp or 12.5 mL |
| 72-95 | 11 | 3 tsp or 15 mL |
Other Information
- Store at room temperature 15° - 30°C (59° - 86°F)
- Protect from Freezing.
- Protect from Light.
- each teaspoon (5 mL) contains: sodium 3 mg
- TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
Inactive Ingredients
butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, D&C red #33. FD&C red # 40, flavor, glycerin, propylene glycol, water, sodium benzoate, sorbitol, xanthan gum, Sodium saccharin.
* Please review the disclaimer below.
