Other
Drug Facts
Alcohol Free, Aspirin Free, Dye Free, Gluten Free, Ibuprofen Free
Distributed By
Perrigo Company
Allegan, MI 49010
Packaged By
Precision Dose, Inc.
South Beloit, IL 61080
LI1531 Rev. 03/22
The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose Inc. for the product Dye Free Childrens Acetaminophen (NDC 68094-061). 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 other, active ingredient (in each 5 ml), purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Alcohol Free, Aspirin Free, Dye Free, Gluten Free, Ibuprofen Free
Distributed By
Perrigo Company
Allegan, MI 49010
Packaged By
Precision Dose, Inc.
South Beloit, IL 61080
LI1531 Rev. 03/22
Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily:
This product contains acetaminophen. Severe liver damage may occur if your child takes
Acetaminophen may cause a 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 liver disease
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 (see overdose warning)
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 right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
| Weight (lb) | Age (yr) | Dose (mL) or as directed by a doctor |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate
1-800-397-9228
NDC 68094-061-61
5 mL per unit dose cup
One hundred (100) cups per shipper
NDC 68094-061-62
5 mL per unit dose cup
Thirty (30) cups per shipper
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
* Please review the disclaimer below.