Active Ingredient
(in each 5 mL)
Acetaminophen160 mg
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Childrens Acetaminophen Oral Suspension (NDC 60687-762). 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, purpose, usestemporarily:, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 5 mL)
Acetaminophen160 mg
Pain reliever/fever reducer
Liver warning: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.
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.
Ask a doctor before use if your child hasliver disease.
Ask a doctor or pharmacist before use if your childis 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 for adults as well as children even if you do not notice any sign 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 (1 unit dose cup) |
36-47 | 4-5 years | 7.5 mL (1.5 unit dose cups) |
48-59 | 6-8 years | 10 mL (2 unit dose cups) |
60-71 | 9-10 years | 12.5 mL (2.5 unit dose cups) |
72-95 | 11 years | 15 mL (3 unit dose cups) |
grape flavored suspension supplied in the following oral dosage form:
5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17
acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
Call 1-800-845-8210.
DO NOT USE IF SEAL IS BROKEN.
Distributed by:
American Health Packaging
Columbus, OH 43217
T0966C050423
R04/23
Case NDC 60687-762-17/Cup NDC 60687-762-40
Children’s Acetaminophen
Oral Suspension
160 mg per 5 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
USUAL DOSAGE:See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
For Institutional Use Only.
T0966C050423 R04/23
NDC 60687- 762-40
CHILDREN’S
ACETAMINOPHEN
ORAL SUSPENSION
Pain Reliever-Fever Reducer
160 mg per 5 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free
Delivers 5 mL
SHAKE WELL BEFORE USING
See package Drug Facts inert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0966C50423
* Please review the disclaimer below.