Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Childrens Acetaminophen Suspension
FDA Label NDC 0904-7278
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Childrens Acetaminophen (NDC 0904-7278). 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, warnings, directions, other information, inactive ingredients:, questions or comments?, 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 pain due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
Liver warning: This product contains 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
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 fever, headache, rash, nausea, or vomiting, consult a doctor promptly
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 of the inactive ingredients in this product.
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 the recommended dose (see overdose warning)
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.
Directions
- this product does not contain directions or complete warnings for adult use
- do not take more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
| Weight (lb) | Age (yr) | Dose (mL) * |
| Under 24 | Under 2 | 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 |
*or as directed by a doctor
Other Information
- each 5 mL contains: sodium 2 mg
- Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
- protect from freezing
- a red, berry flavored suspension supplied in the following oral dosage form: NDC 0904-7278-41: 5 mL unit dose cup, in a tray of ten cups
Inactive Ingredients:
Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
Questions Or Comments?
Call 1-800-845-8210.
Principal Display Panel - 5 Ml Unit Dose Cup
MAJOR®
0904-7278-41
Children's Acetaminophen Oral Suspension
160 mg per 5 mL
Pain Reliever • Fever Reducer
Ibuprofen Free/ Alcohol Free / Aspirin Free
SHAKE WELL
Delivers 5 mL • See insert
For Institutional Use Only
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
A1781C050882
5 mL Unit Dose Cup Label (Childrens Apap Major 1)
* Please review the disclaimer below.
